Medtronic MICSIMPLANT Internal to body medical implant User Manual

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Document Title	Users Manual

PRELIMINARY DRAFT
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MARQUIS II DRXXXX
Dual Chamber Implantable Cardioverter Defibrillator -- DRAFT
Implant Manual
Caution: Federal law (USA) restricts this
device to sale by or on the order of a
physician or properly licensed practitioner.
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The following are trademarks of Medtronic.
Active Can, CapSure, Cardiac Compass, Flashback, GEM, GEM DR, Marker Channel,
Marquis II, Medtronic, PR Logic, Patient Alert, Quick Look, Sigma
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Table of Contents
1 Description
2 Indications and usage
3 Contraindications
4 Warnings and precautions
4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.8
Storage and handling
Resterilization
Device operation
Lead evaluation and lead connection
Follow-up testing
Explant and disposal
Medical therapy hazards
Home and occupational environments
5 Adverse events
6 Clinical studies
10
11
11
11
7 Patient selection and treatment
7.1 Individualization of treatment
7.2 Specific patient populations
9 Conformance to standards
10 How supplied
15
15
15
8 Patient counseling information
16
16
16
11 Clinician use information
16
11.1 Physician training
16
11.2 Directions for use
16
11.3 Maintaining device effectiveness
12 Patient information
13 Implant procedure
13.1
13.2
13.3
13.4
13.5
13.6
13.7
5.1 Observed adverse events
5.2 Potential adverse events
6.1 Acute study
6.2 Implant study
17
17
17
Pre-operative programming
18
Testing lead operation
18
Connecting leads to the implanted device
Defibrillation threshold testing
20
Placing the device
21
Programming
21
Replacing an old ICD
21
14 Feature summary
19
22
14.1 Tachyarrhythmia operations
14.2 Pacing operations
22
22
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14.3 Monitoring operations
15 Product specifications
15.1
15.2
15.3
15.4
15.5
23
23
Physical specifications (nominal)
Replacement indicators
23
Projected longevity
24
Magnet behavior
26
Functional parameters
26
23
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1 Description
The Mode lXXXX Marquis II DR Implantable Cardioverter Defibrillator (ICD) System is a multiprogrammable,
implantable cardioverter defibrillator that monitors and regulates a patient’s heart rate by providing ventricular
arrhythmia therapy, and single or dual chamber rate responsive bradycardia pacing.
The Model XXXX Marquis II DR ICD, along with commercially available pace/sense leads and cardioversion/
defibrillation leads, constitutes the implantable portion of the ICD system. The lead systems for the
Marquis II DR system are implanted using standard transvenous placement techniques.
The Model 9790C programmer, Model 9966 software, Model 9466 patient magnet, Model 9322 SmartMagnet
and Model 9767 (or Model 9767L) programming head constitute one external portion of the ICD system.
The Model 2090 programmer is compatible. Programmers from other manufacturers are not compatible.
Contents of sterile package – The sterile package contains one implantable cardioverter defibrillator, one
torque wrench, and one DF–1 pin plug.
About this manual – This document is intended primarily as an implant manual. Regular patient
follow-up sessions should be scheduled after implant. Follow-up procedures such as monitoring battery
measurements and confirming therapy parameters are described in the manual included with the software
supporting the Model XXXX Marquis II DR ICD. (To obtain additional copies of this manual, contact your
Medtronic representative.)
2 Indications and usage
The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and
ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.
Contraindications
The Marquis II DR system is contraindicated for
•
•
•
•
patients whose tachyarrhythmias may have transient or reversible causes, such as: acute myocardial
infarction, digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia, or sepsis.
patients with incessant VT or VF
patients who have a unipolar pacemaker
patients whose primary disorder is bradyarrhythmias or atrial arrhythmias
4 Warnings and precautions
Avoiding shock during handling – Program tachyarrhythmia detection Off during surgical implant and
explant or post-mortem procedures because the ICD can deliver a serious shock if you touch the defibrillation
terminals while the ICD is charged.
Electrical isolation during implantation – Do not permit the patient to contact grounded equipment,
which could produce hazardous leakage current during implantation. Resulting arrhythmia induction could
result in the patient’s death.
Lead system – Do not use another manufacturer’s lead system without demonstrated compatibility, as
undersensing of cardiac activity and failure to deliver necessary therapy could result.
Resuscitation availability – Do not perform ICD testing unless an external defibrillator and medical
personnel skilled in cardiopulmonary resuscitation (CPR) are readily available.
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4.1
Storage and handling
Checking and opening the package – Before opening the sterile package tray, visually check for any signs
of damage that might invalidate the sterility of its contents. Return damaged packages to the manufacturer.
For instructions on opening the sterile package, see the diagram inside the lid of the shelf box.
Device storage – Store the device in a clean area, away from magnets, kits containing magnets, and
sources of electromagnetic interference to avoid device damage.
Dropped device – Do not implant the device if it has been dropped on a hard surface from a height of 30 cm
(12 in) or more after removal from its packaging.
Equilibration – Allow the device to reach room temperature before programming or implanting, because
rapid temperature changes could affect initial device function.
Temperature limits – Store and transport the package between -18 C (0 F) and +55 C (+131 F).
“Use By” Date – Do not implant the device after the “Use By” date because the battery longevity could
be reduced.
4.2
Resterilization
Medtronic has sterilized the device package contents with ethylene oxide prior to shipment. Resterilization is
necessary only if the seal on the sterile package is broken. (Resterilization does not affect the "Use By"
date.) If necessary, resterilize with ethylene oxide using a validated sterilization process, observing the
following precautions:
•
Do not resterilize the device using an autoclave, gamma radiation, organic cleaning agents (such as
alcohol, acetone, etc.), or ultrasonic cleaners.
•
•
Do not resterilize the device more than twice.
Do not exceed 55 C (131 F) or 103 kPa (15 psi) when sterilizing.
4.3
Device operation
Accessories – The device may be used only with accessories, parts subject to wear and disposable items,
of which the completely safe use on safety and technical grounds has been demonstrated by a testing
agency approved for the testing of the device.
Battery depletion – Battery depletion will eventually cause the device to cease functioning and should be
carefully monitored. Cardioversion and defibrillation are high energy therapies and may quickly deplete
the battery and shorten the device longevity. An excessive number of charging cycles will also shorten
the longevity.
Charge Circuit Timeout or Charge Circuit Inactive – Replace the device immediately if the programmer
displays a Charge Circuit Timeout or Charge Circuit Inactive message.
Concurrent pacemaker use – If a pacemaker is used concurrently with the ICD, verify that the ICD will not
sense the pacemaker output pulses. Program the pacemaker so that pacing pulses are delivered at intervals
longer than the ICD tachyarrhythmia detection intervals.
End of Life (EOL) indicator – Replace the device immediately if the programmer displays an End of
Life (EOL) symbol.
Higher energy on the output capacitor – A higher than programmed energy can be delivered to the
patient when the device has been previously charged to a higher energy and the energy is still present on
the output capacitors.
Lead compatibility – Do not use another manufacturer’s lead system without demonstrated compatibility as
undersensing of cardiac activity and failure to deliver necessary therapy could result.
Medical treatment influencing device operation – The electrophysiological characteristics of a patient’s
heart can alter over time and the programmed therapies may become ineffective and even dangerous to the
patient. This is especially to be considered when the patient’s drug treatment has changed.
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Pacemaker dependent patients – Always program Ventricular Safety Pacing (VSP) On for pacemaker
dependent patients.
Programmers – Use only Medtronic programmers, application software, and accessories to communicate
with the device.
Use of a magnet – Positioning a magnet over the device suspends detection and treatment but does not
alter bradycardia therapy. The programming head contains a magnet that can suspend detection, but if
telemetry between the device and programmer is established, detection is not suspended.
4.4
•
•
•
•
•
•
Lead evaluation and lead connection
Use only ethylene oxide for lead resterilization. Do not resterilize more than one time.
Do not tie a ligature directly to the lead body, tie it too tightly, or otherwise create excessive strain at
the insertion site as this can damage the lead.
Do not immerse leads in mineral oil, silicone oil, or any other liquid.
Do not grip the lead with surgical instruments.
Do not use excessive force or surgical instruments to insert a stylet into a lead.
Use the same polarity evaluated during testing when connecting the leads to the ICD to ensure
defibrillation effectiveness.
•
Do not fold, alter, or remove any portion of the patch because doing so could compromise electrode
function or longevity.
•
Do not use ventricular transvenous leads in patients with tricuspid valve disease or a mechanical
prosthetic tricuspid valve. Use with caution in patients with a bioprosthetic valve.
Use the correct suture sleeve (when needed) for each lead to immobilize the lead and protect it against
damage from ligatures.
Ensure that the defibrillation lead impedance is greater than 20 . An impedance below 20 could
damage the ICD.
•
•
•
Do not kink the leads. Kinking leads can cause additional stress on the leads, possibly resulting
in lead fracture.
•
Do not suture directly over the lead body as this may cause structural damage. Use the lead anchoring
sleeve to secure the lead lateral to the venous entry site.
•
Lead or Active Can electrodes in electrical contact during a high voltage therapy could cause current to
bypass the heart, possibly damaging the ICD and leads. While the ICD is connected to the leads, make
sure that no therapeutic electrodes, stylets, or guidewires are touching or connected by an accessory
low impedance conductive pathway. Move objects made from conductive materials (e.g., an implanted
guidewire) well away from all electrodes before a high voltage shock is delivered.
•
Make sure to cap any pacing lead that is abandoned rather than removed to ensure that the lead does
not become a pathway for currents to or from the heart.
•
•
Make sure to plug any unused lead port in the device to protect the ICD.
Refer to the lead technical manuals for specific instructions and precautions about lead handling.
4.5
Follow-up testing
•
Ensure that an external defibrillator and medical personnel skilled in cardiopulmonary resuscitation
(CPR) are present during post-implant ICD testing should the patient require external rescue.
•
Be aware that changes in the patient’s condition, drug regimen, and other factors may change the
defibrillation threshold (DFT), which may result in nonconversion of the arrhythmia post-operatively.
Successful conversion of ventricular fibrillation or ventricular tachycardia during testing is no assurance
that conversion will occur post-operatively.
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4.6
Explant and disposal
•
Interrogate the ICD, program VF and VT Detection Off, and disable ICD functions prior to explanting,
cleaning, or shipping the ICD to prevent unwanted shocks.
•
Explant the ICD postmortem. In some countries, explanting battery-operated implantable devices is
mandatory because of environmental concerns; please check your local regulations. In addition, if
subjected to incineration or cremation temperatures, the device could explode.
•
Medtronic implantable devices are intended for single use only. Do not resterilize and re-implant
explanted devices.
Please return explanted devices to Medtronic for analysis and disposal. See the back cover for mailing
addresses.
•
4.7
Medical therapy hazards
Diathermy – People with metal implants such as pacemakers, implantable cardioverter defibrillators (ICDs),
and accompanying leads should not receive diathermy treatment. The interaction between the implant and
diathermy can cause tissue damage, fibrillation, or damage to the device components, which could result in
serious injury, loss of therapy, and/or the need to reprogram or replace the device.
Electrosurgical cautery – Electrosurgical cautery could induce ventricular arrhythmias and/or fibrillation,
or may cause implanted device malfunction or damage. If electrocautery cannot be avoided, observe the
following precautions to minimize complications:
•
•
•
•
•
•
Have temporary pacing and defibrillation equipment available.
Program the implanted device to the DOO mode.
Suspend tachyarrhythmia detection using a magnet, or turn detection Off using the programmer.
Avoid direct contact with the implanted device or leads. If unipolar cautery is used, position the ground
plate so that the current pathway does not pass through or near the implanted device system (minimum
of 15 cm [6 in]).
Use short, intermittent, and irregular bursts at the lowest feasible energy levels.
Use a bipolar electrocautery system, where possible.
External defibrillation – External defibrillation may damage the implanted device or may result in temporary
and/or permanent myocardial damage at the electrode tissue interface as well as temporary or permanent
elevated pacing thresholds. Attempt to minimize the voltage potential across the device and leads by
following these precautions:
•
•
Use the lowest clinically appropriate energy output.
Position defibrillation patches or paddles as far from the device as possible (minimum of 15 cm [6 in]),
and perpendicular to the implanted device-lead system.
If an external defibrillation was delivered within 15 cm (6 in) of the device, contact your Medtronic
representative.
High-energy radiation – Diagnostic X-ray and fluoroscopic radiation should not affect the device; however,
high-energy radiation sources such as cobalt 60 or gamma radiation should not be directed at the device. If a
patient requires radiation therapy in the vicinity of the device, place lead shielding over the implant site as a
precaution against radiation damage.
Lithotripsy – Lithotripsy may permanently damage the implanted device if it is at the focal point of the
lithotripsy beam. If lithotripsy must be used, temporarily turn off ICD therapies during the lithotripsy procedure
and keep the focal point of the lithotripsy beam at least 2.5 to 5 cm (1 to 2 in) from the implanted device.
Magnetic resonance imaging (MRI) – Magnetic resonance imaging (MRI) should not be used on patients
who have an implanted cardiac device because of the potential damage to the implanted device.
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Radio frequency (RF) ablation – Radio frequency ablation procedure in a patient with an implanted cardiac
device could cause implanted device malfunction or damage. To minimize the risks from radio frequency
ablation,
•
•
•
•
•
Have temporary pacing and defibrillation equipment available.
Program the implanted device to the DOO mode.
Suspend tachyarrhythmia detection using a magnet, or turn detection Off using the programmer.
Avoid direct contact between the ablation catheter and the implanted lead or device.
Position the ground plate so that the current pathway does not pass through or near the implanted
device system (minimum of 15 cm [6 in]).
Therapeutic ultrasound – Exposure of the device to therapeutic ultrasound is not recommended as it may
permanently damage the device. Damage to the device may affect therapy.
4.8
Home and occupational environments
Cellular phones – Marquis II DR ICDs contain a filter that prevents most cellular phone transmissions from
interacting with device operation. To further minimize the possibility of interaction, observe the following
cautions:
•
•
•
•
Maintain a minimum separation of 15 cm (6 in) between the device and the hand-held telephone handset.
Maintain a minimum separation of 30 cm (12 in) between the device and any antenna transmitting
above 3 watts.
Hold the handset to the ear furthest from the implanted device.
Do not carry the handset within 15 cm (6 in) of the implanted device (even if the handset is not on).
The ICD has been tested using the ANSI/AAMI PC-69 standard to ensure compatibility with hand-held
wireless and PCS phones and other similar power hand-held transmitters. These transmission technologies
represent the majority of the cellular telephones in use worldwide. The circuitry of this device, when operating
under nominal conditions, has been designed to eliminate any significant effects from the cellular telephones.
Commercial electrical equipment – Commercial electrical equipment such as arc welders, induction
furnaces, or resistance welders could generate enough EMI to interfere with device operation if approached
too closely.
Communication equipment – Communication equipment such as microwave transmitters, line power
amplifiers, or high-power amateur transmitters could generate enough EMI to interfere with device operation
if approached too closely.
Electric or magnetic interference (EMI) – Patients should be directed to avoid devices that generate strong
electric or magnetic interference (EMI). EMI could cause malfunction or damage resulting in prevention of
proper programming, or confirmation, non-detection or delivery of unneeded therapy. Moving away from the
interference source, or turning it off, usually allows the device to return to its normal mode of operation.
Electronic article surveillance (EAS) – EAS equipment such as retail theft prevention systems may interact
with the implanted device. Patients should be advised to walk directly through, and not to remain near an
EAS system longer than is necessary.
High voltage lines – High voltage power transmission lines could generate enough EMI to interfere with
device operation if approached too closely.
Home appliances – Home appliances which are in good working order and properly grounded do not usually
produce enough EMI to interfere with device operation. There are reports of temporary disturbances caused
by electric hand tools or electric razors used directly over the implant site.
Static magnetic fields – Patients should avoid equipment or situations where they would be exposed to
static magnetic fields (greater than 10 gauss or 1 millitesla) since it could suspend detection. Examples of
magnetic sources that could interfere with normal device operation include: stereo speakers, bingo wand,
extractor wand, magnetic badges, or magnetic therapy products.
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5 Adverse events
5.1
Observed adverse events
Clinical studies were not performed on the Marquis II DR. Because of the similarity between the Marquis II DR
and the GEM DR, clinical data generated by the GEM DR implant study was used to support the Marquis II DR.
The Clinical study of the GEM DR system (approved October 1998) included 300 ICDs implanted in 300
patients worldwide, and 297 Model 6940 CapSure Fix leads implanted in 295 patients worldwide. Total
ICD exposure was 828 device months. Individual patient exposure averaged 2.8 months (ranging from
0 to 5.3 months).
Each adverse event was reviewed by an independent clinical events committee to determine whether it
was related to the ICD system and/or the implantation procedure. There were a total of 15 deaths in the
300 patient clinical study; all were judged to be non-ICD related by the clinical events committee. Table 1
reports the causes of patient death during the clinical study in descending order of frequency. Except where
noted, all deaths were non-sudden cardiac deaths.
Table 1. Patient deaths during the clinical study performed on GEM DR (approved Oct. 1998) (N=300)
Cause of Deaths (15 deaths total)
# of Patients
When occurred (days after
implant)
Congestive heart failure
Cardiac and/or respiratory arrest or failure
5a
Cardiogenic shock
Electromechanical dissociation
1a
118
Ischemic cardiomyopathy
28
Pneumonia
64
21, 50, 68, 77, 89
1, 4, 20, 21, 64
12, 45
One sudden cardiac death.
In the 300 patient clinical study one (1) device was explanted due to inappropriate VT detections.
The following adverse events were observed during the implant procedure (prior to skin closure): helix
extension failure (4 patients); cut in ventricular lead (1 patient); ST elevation (1 patient); electromechanical
dissociation (1 patient).
Table 2 and Table 3 report the adverse events attributed to the ICD system and/or implant procedure, on a
per patient and per patient-year basis in descending order of frequency. The tables list complications and
observations that occurred more than once. Complications and observations that occurred only once
are listed following Table 2 and following Table 3.
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Table 2. Complications related to ICD system and/or implant procedure (all patients, N=300): multiple
complications. Data from GEM DR clinical study (approved Oct. 1998).
# of Patients
% of
Patients
# of Events
Events per
Patient-Year
Complications a (total, including
single complications)
24
8.0%
31
0.45
Atrial lead dislodgement
13
4.3%
13
0.19
Pneumothorax
1.7%
0.07
Ventricular lead dislodgement
1.0%
0.04
Hematoma
0.7%
0.03
Respiratory failure
0.7%
0.03
Complications are adverse events that required invasive intervention. Complications that occurred in only
one patient are listed following the table. Some patients had more than one type of adverse event.
Single complications – Each of the following was observed once in one patient in the 300 patient clinical
study: Atrial oversensing/undersensing; Failure to capture ventricle; Inappropriate ventricular detection;
Increased pulse width threshold (atrium); Infection; and Protrusion under skin.
Table 3. Observations related to ICD system and/or implant procedure (all patients, N=300): multiple
observations. Data from GEM DR clinical study (approved Oct. 1998).
# of
Patients
% of
Patients
# of
Events
Events per
Patient-Year
134
44.7%
189
2.74
Incisional pain
66
22.0%
67
0.97
Inappropriate ventricular detection
23
7.7%
29
0.42
Patient Alert tone triggered
11
3.7%
14
0.20
Atrial oversensing/undersensing
10
3.3%
11
0.16
Hematoma
2.3%
0.10
Atrial fibrillation/flutter
2.0%
0.09
0.09
Observations a (total, including single
observations)
Incessant ventricular tachyarrhythmia
2.0%
Ecchymosis
1.3%
0.06
CHF/CHF exacerbation
1.0%
0.06
Increased DFT
1.0%
0.04
Ventricular oversensing
1.0%
0.04
Inadequate pace/sense measurements
(atrium)
0.7%
0.03
Increased pacing threshold
0.7%
0.06
Infection
0.7%
0.03
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Table 3. Observations related to ICD system and/or implant procedure (all patients, N=300): multiple
observations. Data from GEM DR clinical study (approved Oct. 1998). (continued)
# of
Patients
% of
Patients
# of
Events
Events per
Patient-Year
Pacemaker mediated tachycardia
0.7%
0.03
Palpitations
0.7%
0.03
Observations are adverse events that did not require invasive intervention. Observations that occurred in
only one patient are listed following the table. Some patients had more than one type of adverse event.
Single observations – Each of the following was observed once in one patient in the 300 patient clinical
study: Awareness of ventricular pacing; Bronchitis; Cardiogenic shock; Cellulitis; Cut in outer lead insulation
of 6940 lead during repositioning; Delayed wound healing; Dizziness; Failure to defibrillate/cardiovert;
Fatigue; Fever; Frequent spontaneous SVTs; Generator migration; Inadequate pace/sense measurements
(ventricle); Insomnia; Lethargy; Multisystem failure; Near syncope; Pericardial effusion; Pneumothorax;
Pulmonary edema; Respiratory failure; Subclavian vein thrombosis; and VF therapy delivered despite
spontaneous episode termination.
5.2
Potential adverse events
Adverse events in alphabetical order, including those reported in Table 2 and Table 3, associated with
ICD systems include:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Acceleration of arrhythmias (caused by ICD) Air embolism
Bleeding
Chronic nerve damage
Erosion
Excessive fibrotic tissue growth
Extrusion
Fluid accumulation
Formation of hematomas or cysts
Inappropriate shocks
Infection
Keloid formation
Lead abrasion and discontinuity
Lead migration/dislodgment
Myocardial damage
Pneumothorax
Potential mortality due to inability to defibrillate or pace
Shunting current or insulating myocardium during defibrillation
Thromboemboli
Venous occlusion
Venous or cardiac perforation
Patients susceptible to frequent shocks despite antiarrhythmic medical management could develop
psychological intolerance to an ICD system that might include the following: Dependency; Depression; Fear
of premature battery depletion; Fear of shocking while conscious; Fear that shocking capability may be lost;
Imagined shocking (phantom shock).
10
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Clinical studies
Clinical studies were not performed on the Marquis II DR. Because of the similarity between the Marquis II DR
and the GEM DR, the GEM DR implant study was used to support the Marquis II DR. Clinical study of the GEM
DR system (approved October 1998) involved an acute study and an implant study.
6.1
Acute study
The study was conducted in 62 patients undergoing ICD implantation or cardiac electrophysiology (EP)
study using an external device that contained the GEM DR ICD dual and single chamber tachyarrhythmia
detection algorithms.
Patients studied – The patients (44 M / 18 F) had a mean age of 65.7 (range 33 – 87) years, and a mean left
ventricular ejection fraction of 36.8% (range 10 – 70%) (n=37). Arrhythmia histories included non-sustained
VT (24%), atrial fibrillation (19%), VT (18%) (non-exclusive).
Methods – The study evaluated the appropriateness of dual chamber sensing and tachyarrhythmia detection
during induced and simulated cardiac arrhythmias. Arrhythmias (VT, VF, or SVT) were induced in 48 patients
and the episode records evaluated for relative sensitivity and incremental specificity.
Results – In the acute study, the GEM DR dual chamber detection algorithm (PR Logic Criteria for SVT
discrimination) demonstrated relative sensitivity (Table 5) of 98.5% [95% confidence interval of 89.9 – 99.8%]
and incremental specificity (Table 6) of 77.4% [63.7 – 87.0%], compared to the GEM DR single chamber
detection algorithm. No adverse interactions between sensing, pacing and detection were observed. No
adverse events occurred during the study.
6.2
Implant study
This was a non-randomized, prospective study of 300 patients implanted with the GEM DR in the U.S.,
Europe, Canada and Australia. Most (295 patients) also received a Model 6940 CapSure Fix lead. The
mean implant duration was 2.8 months (range 0 to 5.3 months), with a cumulative implant duration of
828 device months.
Patients studied – The patients (238 M / 62 F) had a mean age of 63.5 (range 13 to 90) years and a left
heart ventricular ejection fraction of 37.5% (10% to 82%). The primary indications for implant included
ventricular arrhythmias (47%), ventricular arrhythmias and sudden cardiac death (34%) and sudden cardiac
death (17%). Cardiovascular history included coronary artery disease and myocardial infarction (59%),
dilated cardiomyopathy (30%), congestive heart failure (26%) and hypertension (26%) (non-exclusive).
Methods – The primary objective was to demonstrate unanticipated device related effect 1 (UADRE) -free
survival greater than 90% (lower confidence interval) at three months post-implant. Patients underwent
standard ICD implantation and were evaluated at one month and three months post-implant. The implant
criterion was DFT ≤ 22 J by the binary search method or 2 out of 2 successful defibrillations at ≤ 24 J.
Pacing and sensing were evaluated via ambulatory monitoring of 51 patients. Activity sensor-driven pacing
was evaluated in 20 patients who completed an exercise test. The heart rates at rest and during exercise
were measured, and the physician reported whether or not the exertional rate 2 was acceptable for the
patient’s level of exercise (Table 8). Spontaneous VT/VF episodes were evaluated for therapy effectiveness
(Table 7), relative sensitivity (Table 5), and incremental specificity (Table 6), using the ICD stored episode
records. Patient Alert tone identifiability was evaluated via telephone monitoring at two months post-implant.
Subthreshold (painless) lead impedance testing was performed at each visit.
Any “serious [incapacitating, life threatening, or fatal] unanticipated clinical event related to the ICD,”
excluding random component failure and device misuse.
At the end of stage 3 of the CAEP treadmill exercise challenge.
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Results – The implant study results are detailed in Table 4 through Table 8. Patient Alert tones were
correctly identified by the patient and clinician in 115 of the 119 patients tested (96.6% success [95%
confidence interval of 91.6 – 99.2%]). No unanticipated device-related effects (UADRE) were identified
by the clinical events committee. All pacing and sensing functions evaluated via ambulatory monitoring
performed as intended.
Table 4. Implant study results from GEM DR clinical study (approved Oct. 1998).
Measure
Results
Successes (#)
Patients (#)
171
186
95
108
285
300
276
300
117
117
Results at Implant
% of patients meeting implant criterion of DFT
≤ 22 J with initial lead system using binary
search protocol [95% confidence interval b]
[88.0 – 95.8%]
% of patients meeting implant criterion of 2/2
inductions at ≤ 24 J with initial lead system
[95% confidence interval b]
[81.8 – 94.1%]
91.9%
88.0%
Chronic Results
Overall survival at 3 months [95% confidence
interval a]
94.7%
[89.5 – 97.3%]
Complication-free survival at 3 months [95%
confidence interval a]
92.0%
[88.3 – 94.6%]
UADRE-free survival at 3 months [95%
confidence interval b]
[95.5 – 100.0%]
100.0%
Estimated by the Kaplan-Meier method.
Estimated by the exact binomial method.
Table 5. Relative detection sensitivity, per VT/VF episode: dual chamber algorithm relative to single chamber
algorithm, based on data from GEM DR clinical study (approved Oct. 1998).
Relative Sensitivity a (%)
Acute Study, n =
30 c
[95% c.i.]
Implant Study, n = 66 d [95% c.i.]
Detections of VT/VF (#) by
dual chamber algorithm b
98.5% [89.9 – 99.8%]
67 / 68 e (98.5%)
99.8% [99.2 – 99.9%]
795 / 797 e (99.7%)
As adjusted for multiple episodes within a patient, based on the Generalized Estimating Equations
Model with exchangeable correlation.
Episode data recorded by the external device (acute study) or ICD memory (implant study), using the
GEM DR dual and single chamber detection algorithms.
30 patients with one or more induced VT/VF episodes.
66 patients with one or more spontaneous VT/VF episodes.
Detections of VT/VF episodes by the single chamber algorithm are stated as the denominator.
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Table 6. Incremental detection specificity, per VT/VF episode: dual chamber algorithm relative to single
chamber algorithm based on data from GEM DR clinical study (approved Oct. 1998).
Incremental Specificity (%)
Discrimination of non-VT/VF
(#) by dual chamber
algorithm b
Acute Study, n = 32 c [95% c.i.]
77.4% [63.7 – 87.0%]
43 / 60 e (71.7%)
Implant Study, n = 42 d [95% c.i.]
63.0% [49.0 – 75.1%]
212 / 295 e (71.9%)
As adjusted for multiple episodes within a patient, based on the Generalized Estimating Equations
Model with exchangeable correlation.
Episode data recorded by the external device (acute study) or ICD memory (implant study), using the
GEM DR dual and single chamber detection algorithms.
32 patients with one or more induced SVT episodes.
42 patients with one or more spontaneous SVT episodes.
Detections of non-VT/VF episodes by the single chamber algorithm are stated as the denominator.
Table 7. Spontaneous episode termination effectiveness, per episode based on data from GEM DR clinical
study (approved Oct. 1998).
Effectiveness a
Implant Study, n = 64 b
[95% c.i.]
(%)
99.1% [96.8 – 99.8%]
VT/VF Episodes (#)
Episodes
Successfully
Terminated (#)
1153
1147
As adjusted for multiple episodes within a patient, based on the Generalized Estimating Equations Model
with exchangeable correlation. The unadjusted results are essentially the same.
64 patients with one or more spontaneous VT/VF episodes.
6.2.1 Rate response
Methods – Clinical studies were not performed on the Marquis II DR. Because the same accelerometer-based
rate reponse feature is used by both the Marquis II DR and Sigma 300 DR, the Sigma 300 DR clinical study
(approved August 1999) was used to support the Marquis II DR. This study, conducted at 17 investigational
centers worldwide, was a prospective evaluation of the rate response feature of the Sigma 300 DR
pacemaker. Patient data were collected at implant, pre-discharge, one month, three months, and six months
post-implant.
Objective – Rate response operation was evaluated to demonstrate that increases in pacing rates are
concurrent with increases in workload. Patients were evaluated utilizing a modified version of the Minnesota
Pacemaker Response Exercise Protocol (M-PREP) 3 at their one month visit. Evaluation of rate response
performance was conducted using the Metabolic Chronotropic Response model described by Wilkoff as
applied by Kay 4 . Valid data collected from patients that performed the exercise per protocol for at least three
minutes were included in the analysis.
Description of Patients – A total of 67 patients were enrolled and received an implanted pacemaker. The
mean age was 67.2 years (range: 19.5 to 85.2 years). Patients met the indications for dual chamber pacing:
atrial fibrillation/flutter in 23 patients and normal AV conduction in 13 patients (patients could have more
than one indication). Mean duration of implant was 3.8 months with a range of 0 to 6.9 months and a
total experience of 257 patient months.
Benditt, David G.M., Editor, Rate Adaptive Pacing, Blackwell Scientific Publications, Boston. 1993:63-65.
Kay, Neal G., Quantitation of Chronotropic Response: Comparison of Methods for Rate-Modulating
Permanent Pacemakers. JACC. Dec 92;20(7):1533-41.
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Results of the Study – The rate response clinical study was not performed on the Marquis II DR. Because the
same accelerometer-based rate reponse feature is used by both the Marquis II DR and Sigma 300 DR, the
Sigma 300 DR clinical study (approved August 1999) was used to support the Marquis II DR.
Table 8 provides the results of the clinical study. The performance of the rate response feature was found
to meet the study objective. Each of the 31 patients included in the analysis individually met the minimum
0.65 slope requirement.
Table 8. Effectiveness Analysis based on Sigma 300 DR clinical study (approved Aug. 1999) a
Mean Slope of M-PREP Rate
Response at 1 Month (n=31
patients)
Observed 95% CI (Confidence
Interval)
Performance Objective
Criterion: 95% CI (Confidence
Interval)
1.02
[0.97, 1.06]
[0.65, 1.35]
All patients implanted (n=68 devices in 67 patients totaling 257 device-months).
Figure 1 shows the sensor-indicated rate (SIR) versus the Wilkoff-predicted heart rate achieved during the
M-PREP test at one month.
Figure 1. Rate Response Exercise Data based on Sigma 300 DR clinical study (approved Aug. 1999)
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
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Table 9. Heart rate during activity sensor-driven a pacing, based on GEM DR clinical study (approved Oct.
1998). This table does not apply to Marquis II DR.
Heart Rate (Mean ± s.d.)
Rate at Rest
n = 20 b
Rate During Exercise
n = 20 b
69.9 bpm ± 14.2 bpm
104 bpm ± 15.9 bpm
The type of sensor used by the GEM DR is a piezoelectric crystal. Because the Marquis II DR and GEM
DR do not use the same type of rate response sensor, the GEM DR clinical study for rate response was
not used to support the Marquis II DR.
20 patients with activity sensor-driven pacing during an exercise test. All 20 were judged by the physician
to have attained an adequate heart rate during exercise.
7 Patient selection and treatment
7.1
Individualization of treatment
Pectoral or abdominal implant site – Evaluate the prospective patient’s size and activity level to determine
whether a pectoral or abdominal implant is suitable.
Exercise stress testing – If the patient’s condition permits, use exercise stress testing to:
•
•
•
Determine the maximum rate of the patient’s normal rhythm
Identify any supraventricular tachyarrhythmias
Identify exercise induced tachyarrhythmias.
The maximum exercise rate or the presence of supraventricular tachyarrhythmias may influence selection of
programmable parameters. Holter monitoring or other extended ECG monitoring also may be helpful.
Electrophysiologic (EP) testing – It is strongly recommended that candidates for ICD therapy have a
complete cardiac evaluation including EP testing. EP testing should identify the classifications and rates of
all the ventricular and atrial arrhythmias, whether spontaneous or induced during EP testing.
Drug resistant supraventricular tachyarrhythmias (SVTs) may initiate frequent unwanted device therapy.
A careful choice of programming options is necessary for such patients.
Antiarrhythmic drug therapy – If the patient is being treated with antiarrhythmic or cardiac drugs, the
patient should be on a maintenance drug dose rather than a loading dose at the time of device implantation.
If changes to drug therapy are made, repeated arrhythmia inductions are recommended to verify detection
and conversion. The device also may need to be reprogrammed.
Changes in a patient’s antiarrhythmic drug or any other medication that affects the patient’s normal cardiac
rate or conduction can affect the rate of tachyarrhythmias and/or effectiveness of therapy.
Direct any questions regarding the individualization of patient therapy to a Medtronic representative at
1-800-PCD-INFO (1-800-723-4636).
7.2
Specific patient populations
Pregnancy – If there is a need to image the device, care should be taken to minimize radiation exposure
to the fetus and the mother.
Nursing mothers – Although appropriate biocompatibility testing has been conducted for this implant device,
there has been no quantitative assessment of the presence of leachables in breast milk.
Pediatric patients – This device has not been studied in patients younger than 13 years of age.
Geriatric patients – Most (67%) of the patients receiving the GEM DR ICD in clinical studies were over the
age of 60 years (see Section 6, “Clinical studies”, page 11).
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Handicapped and disabled patients – Special care is needed in using this device for patients using
electrical wheelchairs or other electrical (external or implanted) devices.
8 Patient counseling information
Physicians should consider the following points in counseling the patient about this device:
• Persons administering CPR may experience the presence of voltage on the patient’s body surface
(tingling) when the patient’s device delivers a shock.
• Advise patients to contact their physician immediately if they hear tones coming from their device.
•
Encourage patients to use identification cards (issued by Medtronic) and/or identification bracelets
documenting their device.
Discuss information in the Patient Manual (Restoring the Rhythms of Life and Model 9466 Patient Magnet
Instructions For Use) with patients before and after device implantation so they are fully familiar with
operation of the device. Advise patients how to obtain additional copies of the patient manuals.
9 Conformance to standards
This ICD was developed in conformance with all or parts of the following standards:
•
•
•
•
ISO 5841-3:1992(E), IS-1 IPG Connector Standard.
ISO 11318:1993(E), DF-1 Defibrillator Connector Standard.
EN45502 - Active Implantable Medical Devices, Part 1: General Requirements for Safety, Marking and
Information to be provided by the Manufacturer, August 1997.
prEN45502 - Active Implantable Medical Devices; Part 2-2: Particular Requirements for Active
Implantable Medical Devices Intended to Treat Tachyarrhythmia (Includes Implantable Defibrillators),
March 1998.
• IEC 601-1, Medical Electrical Equipment: General Requirements for Safety.
This information should not be used as a basis of comparisons among devices since different parts of the
standards mentioned may have been used.
10 How supplied
The Model 7274 Marquis II DR device is packaged one per package in a sterile package.
11 Clinician use information
11.1 Physician training
Physicians should be familiar with sterile ICD implant procedure and familiar with follow-up evaluation and
management of patients with a defibrillator (or referral to such a physician).
11.2 Directions for use
Device operating characteristics should be verified at the time of implantation and recorded in the patient file.
Complete the Device Registration Form and return it to Medtronic as it provides necessary information for
warranty purposes and patient tracking.
The Marquis II DR Reference Manual, supplied with the XXXX software, provides complete programming
instructions and recommendations. Copies can be obtained by contacting the Medtronic representative, or
by calling 1-800-PCD-INFO (1-800-723-4636). The Reference Manual was last updated in xxxxxxxxxxxx.
This Implant Manual was last updated xx-xxxx.
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11.3 Maintaining device effectiveness
11.3.1 Device storage
FOR SINGLE USE ONLY. Do not resterilize and reimplant an explanted device. Medtronic has sterilized
the device with ethylene oxide prior to shipment. Resterilizing the device is necessary if the seal on the
sterile package is broken. Resterilization does not affect the “Use By” date because this date is based on
battery life and sterility.
Do not implant the device when:
•
•
•
•
It has been dropped on a hard surface from a height of 30 cm (12 in) or more because this could have
damaged ICD components;
Its storage package has been pierced or altered, because this could have rendered it non-sterile;
It has been stored or transported outside the environmental temperature limits of –18 to +55 C (0 to
131 F), as the device circuitry may have been damaged; or
Its “Use By” date has expired, because this can adversely affect device longevity or sterility.
11.3.2 Sterilization instructions
Do not resterilize the device or the torque wrench using an autoclave, gamma radiation, organic cleaning
agents (e.g., alcohol, acetone, etc.), or ultrasonic cleaners.
Should sterilization be required:
•
•
•
•
Repackage all items in a gas permeable container;
Use a validated ethylene oxide gas process;
Follow the manufacturer’s operation instructions so long as the maximum temperature does not exceed
55 C (131 F), nor pressures of 15 psi;
Store the resterilized components for an appropriate period to permit aeration of ethylene oxide gas.
12 Patient information
Information for the patient is available in a separate booklet, Restoring the Rhythms of Life, from Medtronic
(supplied with the device). To obtain additional copies, contact the Medtronic representative or call
1-800-PCD-INFO (1-800-723-4636). This information should be given to each patient with their device, and
offered to the patient on each return visit or as deemed appropriate.
Restoring the Rhythms of Life was developed using patient and clinician input to ensure that it is
understandable. Restoring the Rhythms of Life was last updated December 2001.
13 Implant procedure
Warnings:
• Do not permit the patient to contact grounded equipment that could produce hazardous leakage current
during implantation. Resulting arrhythmia induction could result in the patient’s death.
• The device is intended for implantation with Medtronic transvenous or epicardial defibrillation leads.
Transvenous (Endotak® series) or epicardial defibrillation leads manufactured by Guidant Corporation
can also be used. No claims of safety and efficacy can be made with regard to other non-Medtronic
acutely or chronically implanted lead systems.
• Lead or Active Can electrodes in electrical contact during a high voltage therapy could cause current
to bypass the heart, possibly damaging the device and leads. While the device is connected to the
leads, make sure that no therapeutic electrodes, stylets, or guidewires are touching or connected by
an accessory low impedance conductive pathway. Move objects made from conductive materials (for
example, an implanted guidewire) well away from all electrodes before a high voltage shock is delivered.
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13.1 Pre-operative programming
Check the “Use By” date printed on the package. Do not implant the device after the “Use By” date, because
the battery’s longevity could be reduced.
Before opening the sterile package, prepare the ICD for implant as follows:
1. Interrogate the ICD and print a full summary report.
2. Confirm that the battery voltage is at least 3.0 V at room temperature. 5
If the device has been exposed to lower temperatures or has delivered a recent high voltage charge, the
battery voltage will be temporarily lower.
3. Set the ICD internal clock.
4. Perform a manual capacitor formation as follows:
•
•
•
•
•
Dump any charge on the capacitors.
Perform a test charge to full energy.
Retrieve the charge data.
Do not dump the stored charge. Allow it to dissipate, thus reforming the capacitors.
If the reported charge time is clinically unacceptable, contact a Medtronic representative.
5. Program the therapy and pacing parameters to values appropriate for the patient. Ensure that all
tachyarrhythmia detection is programmed off.
13.2 Testing lead operation
1. Implant endocardial leads according to the supplied instructions, unless suitable chronic leads 6 are
already in place. Do not use any lead with this device without first verifying connector compatibility. A
bipolar atrial lead with closely spaced pacing and sensing electrodes is recommended.
2. Verify appropriate sensing and an adequate pacing threshold margin (Table 10) using an implant support
instrument (PSA), according to its supplied instructions.
Table 10. Acceptable Implant Values a
Measurements required
Acute transvenous leads
Chronic leads b
R-wave amplitude
≥ 5 mV
≥ 3 mV
P-wave amplitude
≥ 2 mV
≥ 1 mV
Slew rate
≥ 0.5 V/s (atrial)
≥ 0.3 V/s (atrial)
≥ 0.75 V/s (ventricular)
≥ 0.5 V/s (ventricular)
Capture threshold (0.5 ms pulse
width)
≤ 1.5 V (atrial)
≤ 3.0 V (atrial)
≤ 1.0 V (ventricular)
≤ 3.0 V (ventricular)
V. Defib. impedance
20 - 200
Use the Quick Look screen to verify the voltage.
Chronic leads are leads implanted for 30 days or more.
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Table 10. Acceptable Implant Values a (continued)
Chronic leads b
Measurements required
Acute transvenous leads
SVC (HVX) Defib. impedance c
20 - 200
Defibrillation threshold d
≤ 20 J (two consecutive) or
≤ 18 J (binary search)
The measured pacing lead impedance is a reflection of measuring equipment and lead technology. Refer
to the lead technical manual for acceptable impedance values.
Chronic leads are leads implanted for 30 days or more.
This measurement only applies if a supplementary electrode is connected to the SVC (HVX) port.
If a two-electrode system fails to meet the implant criterion, a third electrode can be added using the
SVC port.
13.3 Connecting leads to the implanted device
Warning: Loose lead connections may result in inappropriate sensing and failure to deliver necessary
arrhythmia therapy.
Caution: Use only the torque wrench supplied with the device. It is designed to prevent damage to the
device from overtightening a setscrew.
For easier lead insertion, insert the ventricular IS-1 leg before the other legs.
Table 11. Lead Connections
Device Port
Connector Type
Software Name
SVC
DF-1
HVX
RV
DF-1
HVB
Can
n/a
HVA, Can
IS-1 bipolar
IS-1 bipolar
Figure 2. Lead connections
SVC
RV
13.3.1 Lead connection procedure
1. Insert the torque wrench into the appropriate setscrew.
a. If the port is obstructed, retract the setscrew to clear it. Take care not to disengage the setscrew
from the connector block.
b. Leave the torque wrench in the setscrew until the lead is secure. This allows a pathway for venting
trapped air when the lead is inserted.
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2. Push the lead or plug into the connector port until the lead pin is clearly visible in the pin viewing area.
No sealant is required, but sterile water may be used as a lubricant.
3. Tighten the setscrew by turning clockwise until the torque wrench clicks.
4. Tug gently on the lead to confirm a secure fit. Do not pull on the lead until all setscrews have been
tightened.
5. Repeat these steps for each lead.
Figure 3. Inserting a lead into the device
1 Lead
2 Setscrew block is located behind grommet
3 Tip of lead extends past setscrew block
13.4 Defibrillation threshold testing
Warning: Ensure that an external defibrillator is charged for a rescue shock.
1. Place the programming head over the ICD, start a patient session, and interrogate the device, if you
have not already done so.
2. Observe the Marker Channel annotations to verify that the ICD is sensing properly.
3. Conduct a manual Lead Impedance Test to verify the defibrillation lead connections. Perform this test
with the ICD in the surgical pocket and keep the pocket very moist. If the impedance is out of range,
perform one or more of the following tasks:
•
•
•
•
Recheck lead connections and electrode placement.
Repeat the measurement.
Inspect the bipolar EGM for abnormalities.
Measure the defibrillation impedance with a manual test shock.
4. Program the ICD or support instrument to properly detect VF with an adequate safety margin (1.2 mV
sensitivity).
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5. Program the defibrillation parameters to the desired settings to be tested.
6. Induce and terminate VF using the ICD or support instrument and the implanted lead system (Table 10).
Proper post-shock sensing must be observed.
13.5 Placing the device
Cautions:
•
•
If no SVC electrode is implanted, the pin plug provided with the device must be secured in the SVC port.
Program tachyarrhythmia detection Off before closing.
13.5.1 Placing the device procedure
1. Ensure that each lead pin or plug is fully inserted into the connector block and that all setscrews are tight.
2. Coil any excess lead length beneath the device. Avoid kinks in the lead conductors.
3. Implant the device within 5 cm of the skin. This position optimizes the ambulatory monitoring operations.
4. Suture the device securely within the pocket to minimize post-implant rotation and migration of the
device. Use a normal surgical needle to penetrate the suture holes.
Figure 4. Suture holes
13.6 Programming
1. After closing the pocket, program detection On. Program ventricular tachyarrhythmia therapies On
as desired.
2. Do not enable the Other 1:1 SVTs PR Logic detection criterion until the atrial lead has matured
(approximately one month post implant).
3. If external equipment was used to conduct the defibrillation efficacy tests, perform a final VF induction
and allow the implanted system to detect and treat the arrhythmia.
13.7 Replacing an old ICD
1. Program all tachyarrhythmia detection Off.
2. Dissect the leads and the device free from the pocket. Be careful not to nick or breach the lead insulation.
3. Loosen each setscrew, and gently retract the lead from the connector block.
4. Remove the ICD from the surgical pocket.
5. If the connector pin of any implanted lead shows signs of pitting or corrosion, replace the implanted
lead with a new lead. The damaged lead should be discarded and replaced to assure the integrity
of the device system.
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6. Measure sensing, pacing, and defibrillation efficacy using the replacement ICD or an implant support
instrument.
7. Evaluate the defibrillation efficacy of the replacement system.
You may need an adaptor that will enable connection of the device to the implanted leads (Table 13, page 23).
14 Feature summary
See the “Shipped” column of the tables in Section 15.5, page 26, for a list of which features are enabled
at shipping.
14.1 Tachyarrhythmia operations
Anti-tachycardia pacing therapies – Deliver rapid pacing pulses to overdrive and terminate the detected
arrhythmia.
Auto-adjusting sensitivity – Automatically adjusts the sensitivity thresholds following certain paced and
sensed events to reduce the incidence of T-wave sensing and cross-chamber sensing.
Committed defibrillation therapy – Up to six automatic defibrillation shocks to treat VF. Therapy is delivered
asynchronously if synchronization fails. Tilt is fixed at 50%.
High rate timeout – Disables supplementary SVT detection criteria when a ventricular episode exceeds a
programmed duration.
PR Logic SVT discrimination – Withholds inappropriate ventricular detection during episodes of rapidly
conducted supraventricular tachycardia (SVTs), using pattern and rate analysis to identify different SVTs.
Reconfirm VF – Aborts the first defibrillation therapy if synchronization fails.
Stability criterion – Withholds VT detection for rapid rhythms (in the VT detection zone) with irregular
intervals.
Synchronized cardioversion therapy – Up to six shocks to treat VT or FVT. Tilt is fixed at 50% for
all ventricular cardioversion.
14.2 Pacing operations
Mode Switch – Prevents tracking of paroxysmal atrial tachycardias by switching from a tracking mode to
a non-tracking mode.
Non-Competitive Atrial Pacing (NCAP) – Delays an atrial pace from falling within the atrium’s relative
refractory period.
Pacemaker-Mediated Tachycardia (PMT) Intervention – Provides automatic detection and interruption
of pacemaker-defined PMTs.
Premature Ventricular Contraction (PVC) response – Extends the atrial refractory period following a PVC
to promote dual chamber synchrony and cycle length regularity.
Rate Adaptive AV (RAAV) – Varies the Paced AV (PAV) and Sensed AV (SAV) intervals as the heart rate
increases or decreases during dual chamber operation.
Rate Responsive Pacing – Varies the pacing rate in response to the patient’s physical motion as detected
by an activity sensor.
Ventricular Rate Stabilization – Adjusts the ventricular escape interval dynamically to eliminate abrupt
variations in the cycle length.
Ventricular Safety Pacing – Prevents inappropriate inhibition of ventricular pacing caused by crosstalk or
ventricular oversensing.
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14.3 Monitoring operations
Cardiac Compass trends – Plots long term trends in heart rhythm and device status for up to 14 months.
Episode data and EGM storage – Records diagnostic quality electrogram during every detected arrhythmia
episode.
Flashback memory – Stores dual chamber intervals for several minutes prior to recent detected arrhythmia
episodes, and prior to interrogation.
Holter telemetry – Allows the implanted device to continuously transmit an EGM with marker telemetry,
with or without applying the programming head, for up to 46 hours.
Patient Alert – Notifies the patient with an audible tone if the device identifies any of the programmed
or automatic alert conditions.
15 Product specifications
15.1 Physical specifications (nominal)
Table 12. ICD physical characteristics a
36 cc
Volume
Mass
75 g
H x W x Db
68.3 mm x 50.8 mm x 13.9 mm
Surface area of device can
66 cm2
Radiopaque ID c
PKC
Measurements are nominal values based on CAD (computer aided design) model measurements,
and are rounded to the nearest unit.
Grommets may protrude slightly beyond the can surface.
Engineering series number follows the radiopaque code.
15.1.1 Materials
The device presents the following materials into contact with human tissue: titanium; polyurethane; silicone
rubber. These materials have been successfully tested for the ability to avoid biological incompatibility. The
device does not produce an injurious temperature in the surrounding tissue.
15.1.2 Lead compatibility
Table 13. Compatible adaptors
Port
Primary Lead
RV, SVC
DF-1 a
Lead Adaptor
6707 for 6.5 mm cardioversion/defibrillation lead
A, V
IS-1 a bipolar
5866-24M for 5 mm paired unipolar
5866-24M for 5 mm bifurcated
5866-38M for IS-1 unipolar
5866-40M for Medtronic 3.2 mm low-profile
DF-1 refers to the international standard ISO 11318:1993. IS-1 refers to ISO 5841-3:1992(E).
15.2 Replacement indicators
Battery voltage and messages about replacement status appear on the programmer display and on printed
reports. Table 14 lists the Elective Replacement Indicator (ERI) and the End of Life (EOL) conditions.
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Table 14. Replacement indicators
Elective Replacement (ERI)
≤ 2.62 V
End of Life (EOL)
3 months after ERI
EOL indication – If the programmer indicates that the device is at EOL, replace the device immediately.
ERI date – The programmer displays the date when the battery reached ERI on the Quick Look and Battery
and Lead Measurements screens.
Post-ERI conditions – EOL device status is defined as three months following an ERI indication assuming
the following post-ERI conditions: 100% DDD pacing at 60 ppm, 3 V, 0.4 ms; 500 pacing load; and six 30 J
charges. EOL may be indicated before the end of three months if the device exceeds these conditions.
Temporary voltage decrease – The battery voltage temporarily decreases following a high voltage charge.
If a battery measurement is taken immediately after a high voltage charge, ERI or EOL indicator may be
displayed. However, this is a temporary status which will return to normal when the battery has recovered
from the charge.
15.3 Projected longevity
Longevity estimates are based on accelerated battery discharge data and device modeling at 60 ppm
pacing rate, with:
• 2.5 V pacing pulse amplitude, 0.4 ms pacing pulse width, and 30 J delivered therapy energy (see
Table 15)
• 3 V pacing pulse amplitude, 0.4 ms pacing pulse width, and 30 J delivered therapy energy (see Table 16)
This model assumes default automatic capacitor formation setting, as described in the Marquis II DR Reference
manual. As a guideline, each full energy charge decreases device longevity by approximately 24 days.
Device longevity is affected by how certain features are programmed, such as EGM pre-storage. For more
information, see the Optimizing longevity chapter of the Marquis II DR Reference manual.
Considerations for using EGM pre-storage – When the EGM pre-storage feature is programmed off, the
device starts to store EGM following the third tachyarrhythmia event and also provides up to 20 seconds of
information before the onset of the tachyarrhythmia, including:
•
•
•
AA and VV intervals
Marker Channel
interval plot Flashback
When the EGM pre-storage feature is programmed on, the device also collects up to 20 seconds of EGM
information before the onset of the arrhythmia.
In a patient who uniformly repeats the same onset mechanisms, the greatest clinical benefit of pre-onset
EGM storage is achieved after a few episodes are captured. To maximize the effectiveness of the EGM
pre-storage feature and optimize device longevity, consider these programming options:
•
•
Turn pre-storage on to capture possible changes in the onset mechanism following significant clinical
adjustments, for example, device implant, medication changes, and surgical procedures.
Turn pre-storage off once you have successfully captured the information of interest.
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Table 15. Projected longevity in years with 2.5 V pacing amplitude and 0.4 ms pulse width
Percent
pacing
Maximum
energy charging
frequency a
0%
Semi-Annual
Quarterly
15%
Semi-Annual
Quarterly
50%
Semi-Annual
Quarterly
100%
Semi-Annual
Quarterly
500
pacing
impedance
900
pacing
impedance
EGM pre-storage b
DDD
VVI
DDD
VVI
Off
8.6
8.6
8.6
8.6
On
8.5
8.5
8.5
8.5
Off
7.5
7.5
7.5
7.5
On
7.3
7.3
7.3
7.3
Off
8.3
8.5
8.5
8.6
On
8.1
8.4
8.3
8.5
Off
7.2
7.4
7.3
7.5
On
7.0
7.3
7.1
7.3
Off
7.5
8.2
8.0
8.5
On
7.4
8.0
7.9
8.2
Off
6.6
7.1
7.0
7.3
On
6.5
7.0
6.8
7.1
Off
6.7
7.7
7.5
8.1
On
6.5
7.5
7.3
8.0
Off
6.0
6.8
6.6
7.1
On
5.8
6.5
6.4
6.9
Maximum energy charging frequency may include full energy therapy shocks or capacitor formations.
The data provided for programming EGM pre-storage on is based on a 6 month period (two 3-month
follow-up intervals) over the life of the device. Additional use of EGM pre-storage reduces longevity by
approximately 25% or 3 months per year.
Table 16. Projected longevity in years with 3 V pacing amplitude and 0.4 ms pulse width
500
pacing
impedance
pacing
900
impedance
DDD
VVI
DDD
VVI
8.6
8.6
8.6
8.6
On
8.5
8.5
8.5
8.5
Off
7.5
7.5
7.5
7.5
On
7.3
7.3
7.3
7.3
Off
8.1
8.5
8.4
8.6
On
8.0
8.3
8.2
8.4
Off
7.1
7.3
7.3
7.5
On
6.9
7.2
7.1
7.3
Off
7.2
8.0
7.8
8.3
On
7.0
7.8
7.6
8.1
Off
6.4
7.0
6.8
7.2
Percent
pacing
Maximum
energy charging
frequency a
EGM
pre-storage b
0%
Semi-Annual
Off
Quarterly
15%
Semi-Annual
Quarterly
50%
Semi-Annual
Quarterly
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Table 16. Projected longevity in years with 3 V pacing amplitude and 0.4 ms pulse width (continued)
Maximum
energy charging
frequency a
Percent
pacing
100%
Semi-Annual
Quarterly
EGM
pre-storage b
500
pacing
impedance
900
pacing
impedance
DDD
VVI
DDD
VVI
On
6.2
6.8
6.7
7.0
Off
6.2
7.3
7.1
8.0
On
6.0
7.1
7.0
7.7
Off
5.5
6.5
6.3
6.9
On
5.4
6.3
6.1
6.8
Maximum energy charging frequency may include full energy therapy shocks or capacitor formations.
The data provided for programming EGM pre-storage on is based on a 6 month period (two 3-month
follow-up intervals) over the life of the device. Additional use of EGM pre-storage reduces longevity by
approximately 25% or 3 months per year.
15.4 Magnet behavior
Pacing mode
as programmed
Pacing rate and interval
as programmed a
VF, VT, and FVT detection
suspended b
Patient Alert audible tones
with programmable alerts enabled:
•
•
•
continuous tone (Test) c
on/off intermittent tone (seek follow-up)
high/low dual tone (urgent follow-up)
with programmable alerts disabled:
•
•
no tone
high/low dual tone (urgent follow-up)
Rate response adjustments are suspended while a Patient Alert tone sounds.
Detection resumes if telemetry is established and the application software is running or it resumes after
the application software has started.
The Test tone does not sound if VF Detection/Therapy Off is the only alert enabled.
15.5 Functional parameters
Programmable parameters are determined by the software used in the programmer. Functional parameters
are measured at body temperature and 500 load (brady parameters) and 75 load (tachy parameters).
Parameter values are “typical” where no tolerance is stated.
If the programmer displays a message that an electrical reset has occurred, contact your Medtronic
representative.
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15.5.1 Emergency settings
Table 17. Emergency parameters
Parameter
Selectable values
Default
Energy
10, 11, …, 16, 18, 20, …, 30 J
Pathway a
AX>B
30 J
—
Defibrillation
Cardioversion
Energy
0.4, 0.6, …, 2, 3, 4, …, 16, 18, 20, …, 30 J
Pathway
AX>B
30 J
—
Fixed burst
Pacing Interval
100, 110, …, 600 ms
V. Pulse Amplitude b
8V
350 ms
—
V. Pulse Width
1.6 ms
—
VVI pacing
Pacing Mode
VVI
—
Lower Rate
70 ppm
—
V. Sensitivity / A. Sensitivity
as programmed
—
V. Pulse Amplitude b
6V
—
V. Pulse Width
1.6 ms
—
V. Pace Blanking
240 ms
—
Hysteresis
Off
—
V. Rate Stabilization
Off
—
If Active Can is Off, the HVA (Can) electrode is not used as part of the high voltage delivery pathway.
Peak pacing amplitude. When tested per CENELEC standard 45502-2-1, the measured
amplitude A depends upon the programmed amplitude Ap and programmed pulse width Wp:
A = Ap x [0.9 – (Wp x 0.145 ms-1)].
15.5.2 Detection parameters
Table 18. Tachyarrhythmia detection parameters
Parameter
Programmable values
Shipped
Nominal
Reset
VF Detection Enable
On, Off
Off
On
On
VF Interval a
240, 250, …, 400 ms
320 ms
320 ms
320 ms
VF Initial NID
12/16, 18/24, 24/32,
30/40, 45/60, 60/80,
75/100, 90/120, 105/140,
120/160
18/24
18/24
18/24
VF Redetect NID
6/8, 9/12, 12/16, 18/24,
21/28, 24/32, 27/36,
30/40
12/16
12/16
12/16
FVT Detection Enable
Off, via VF, via VT
FVT Interval a
200, 210, …, 600 ms
Off
—
Off
—
Off
—
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Table 18. Tachyarrhythmia detection parameters (continued)
Parameter
Programmable values
Shipped
Nominal
Reset
VT Detection Enable
On, Off, Monitor
Off
Off
Off
VT Interval a
280, 290, …, 600 ms
400 ms
400 ms
400 ms
VT Initial NID
12, 16, …, 52, 76, 100
16
16
16
VT Redetect NID
4, 8, 12, …, 52
12
12
12
Stability a
Off, 30, 40, …, 100 ms
Off
Off
Off
AFib / AFlutter b, c
On, Off
Off
Off
Off
Sinus Tach b, c
On, Off
Off
Off
Off
1:1 VT-ST Boundary
35, 50, 66, 75, 85%
50%
50%
50%
Other 1:1 SVTs b
On, Off
Off
Off
Off
SVT Limit a
240, 250, …, 600 ms
320 ms
320 ms
320 ms
High Rate Timeout
Off, 0.75, 1, 1.25, 1.5, 2,
2.5, …, 5, 6, 7, …, 20,
22, 24, …, 30 min
Off
Off
Off
High Rate Timeout
Therapy
Zone Appropriate, Skip
to VF Therapy
Zone
Appropriate
Zone
Appropriate
Zone
Appropriate
A. Sensitivity d, e
0.15, 0.3, 0.45, 0.6, 0.9,
1.2, 1.5, 2.1 mV
0.3 mV
0.3 mV
0.3 mV
Sensitivity d, e
0.15, 0.3, 0.45, 0.6, 0.9,
1.2 mV
0.3 mV
0.3 mV
0.3 mV
V.
The measured intervals are truncated to a 10 ms multiple (e.g., 457 ms becomes 450 ms). The device
uses this truncated interval value when applying the programmed criteria and calculating interval
averages.
Double tachycardia (i.e. “VF/FVT/VT plus SVT”) detection is automatically enabled when any Dual
Chamber SVT criterion is enabled.
The device is shipped with the Sinus Tach and A.Fib / A.Flutter criteria off. However, when VT Detection
is set to On or Monitor, these parameters are set to On.
With a 40 ms sine2 waveform (ventricular sensitivity) or a 20 ms sine2 waveform (atrial sensitivity). When
using the CENELEC waveform, the rated sensing threshold value will be 1.5 times (ventricular) or 1.4
times (atrial) the rated sine2 sensing threshold.
This setting applies to all sensing in this chamber for both tachyarrhythmia detection and bradycardia
pacing operations.
15.5.3 Therapy parameters
Table 19. Tachyarrhythmia therapy parameters
Parameter
Programmable values
Shipped
Nominal
Reset
VF Therapy Status a
On, Off
On
On
On
VT Therapy Status a
On, Off
VT Therapy Type a
CV, Burst, Ramp, Ramp+
None
—
On
—
None
—
FVT Therapy Status a
On, Off
FVT Therapy Type a
CV, Burst, Ramp, Ramp+
None
—
On
—
None
—
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Table 19. Tachyarrhythmia therapy parameters (continued)
Parameter
Programmable values
Shipped
Nominal
Reset
30 J
30 J
30 J
VF therapy (defibrillation) parameters
Energy b, c
0.4, 0.6, …, 1.8, 2, 3, …, 16,
18, 20, …, 30 J
Pathway
AX>B, B>AX
AX>B
AX>B
AX>B
Confirm VF after initial
detection? a, d
Yes, No
Yes
Yes
Yes
Cardioversion parameters
Energy c
0.4, 0.6, …, 1.8, 2, 3, …, 16,
18, 20, …, 30 J
—
30 J
—
Pathway
AX>B, B>AX
—
AX>B
—
Initial # Pulses
1, 2, …, 15
—
6e
—
R-S1 Interval (% R-R)
50, 53, 56, 59, 63, 66, …,
84, 88, 91, 94, 97
—
84 e
—
Interval Decrement a
0, 10, …, 40 ms
—
10 ms
—
# Sequences a
1, 2, 3, …, 10
—
3e
—
Smart Mode a, f
On, Off
—
Off
—
Burst therapy parameters
Ramp therapy parameters
Initial # Pulses
1, 2, …, 15
—
8g
—
R-S1 Interval (% R-R)
50, 53, 56, 59, 63, 66, …,
84, 88, 91, 94, 97
—
91 h
—
Interval Decrement
0, 10, …, 40 ms
—
10 ms
—
# Sequences a
1, 2, …, 10
—
—
Smart Mode a, f
On, Off
—
Off
—
Ramp+ therapy parameters
Initial # Pulses
1, 2, …, 15
—
—
R-S1 Interval (% R-R)
50, 53, 56, 59, 63, 66, …,
84, 88, 91, 94, 97
—
75
—
S1-S2 Interval (% R-R)
50, 53, 56, 59, 63, 66, …,
84, 88, 91, 94, 97
—
69
—
S2-SN Interval (% R-R)
50, 53, 56, 59, 63, 66, …,
84, 88, 91, 94, 97
—
66
—
# Sequences a
1, 2, …, 10
—
—
Smart Mode a, f
On, Off
—
Off
—
Shared therapy parameters
Progressive Episode
Therapies a
On, Off
Off
Off
Off
Active Can
On, Off
On
On
On
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Table 19. Tachyarrhythmia therapy parameters (continued)
Parameter
Programmable values
Shipped
Nominal
Reset
V. Pulse Width
0.03, 0.06, 0.1, 0.2, …,
1.6 ms
1.6 ms
1.6 ms
1.6 ms
V. Amplitude
0.5, 1, …, 4, 5, 6, 8 V
8.0 V
8.0 V
8.0 V
V. Pace Blanking
150, 160, …, 440 ms
240 ms
240 ms
240 ms
ATP Minimum Interval
150, 160, …, 400 ms
200 ms
200 ms
200 ms
This parameter does not apply to manual therapies.
For automatic therapy 3, 4, 5, or 6, energy must be at least 10 J.
Delivered energy based on a biphasic pulse into a 75 load. For energy less than 1 J, tolerance
is ±0.25 J.
Applies only to the first VF therapy that is programmed On.
FVT Burst therapies have the following Medtronic nominal values: Initial # Pulses is 8, R-S1 Interval is
88%, and # Sequences is 1.
Smart Mode is only available for Therapies 1, 2, 3, and 4.
The nominal Initial # of Pulses for manual ramp therapy is 6.
The nominal R-S1 Interval for manual ramp therapy is 97%.
Peak pacing amplitude. When tested per CENELEC standard 45502-2-1, the measured
amplitude A depends upon the programmed amplitude Ap and programmed pulse width Wp:
A = Ap x [0.9 – (Wp x 0.145 ms-1)].
15.5.4 Bradycardia pacing parameters
Table 20. Bradycardia pacing parameters
Parameter
Programmable values
Shipped
Nominal
Reset
Pacing Mode
DDDR, DDD, DDIR, DDI,
AAIR, AAI, VVIR, VVI,
DOO, VOO, ODO
DDD
DDDR
VVI
Lower Rate
30, 35, 40, …, 60, 70,
75, …, 150 ppm
60 ppm
60 ppm
65 ppm
Upper Tracking Rate
80, 85, …, 150 ppm
120 ppm
120 ppm
120 ppm
Upper Sensor Rate
80, 85, …, 150 ppm
120 ppm
120 ppm
120 ppm
Paced AV
30, 40, …, 350 ms
180 ms
180 ms
180 ms
Sensed AV
30, 40, …, 350 ms
150 ms
150 ms
150 ms
PVARP
Varied, 150, 160, …,
500 ms
310 ms
310 ms
310 ms
A. Refractory
150, 160, …, 500 ms
310 ms
310 ms
310 ms
PVAB a
100, 110, …, 310 ms
150 ms
150 ms
150 ms
A. Amplitude b
0.5, 1, …, 3, 3.5, 4, 5, 6 V
3V
3V
4V
A. Pulse Width
0.03, 0.06, 0.1, 0.2, …,
1.6 ms
0.4 ms
0.4 ms
0.4 ms
0.15, 0.3, 0.45, 0.6, 0.9,
1.2, 1.5, 2 mV
0.3 mV
0.3 mV
0.3 mV
150, 160, …, 250 ms
200 ms
200 ms
240 ms
A.
Sensitivity c, d
A. Pace Blanking
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Table 20. Bradycardia pacing parameters (continued)
Parameter
Programmable values
Shipped
Nominal
Reset
V. Amplitude b
0.5, 1, …, 3, 3.5, 4, 5, 6 V
3V
3V
6V
V. Pulse Width
0.03, 0.06, 0.1, 0.2, …,
1.6 ms
0.4 ms
0.4 ms
1.6 ms
V. Sensitivity c, d
0.15, 0.3, 0.45, 0.6, 0.9,
1.2 mV
0.3 mV
0.3 mV
0.3 mV
V. Pace Blanking
150, 160, …, 440 ms
200 ms
200 ms
240 ms
Post-Shock Pacing Parameters
A. Amplitude b
0.5, 1, 1.5, …, 4, 5, 6, 8 V
4V
4V
4V
A. Pulse Width
0.03, 0.06, 0.1, 0.2, …,
1.6 ms
1.6 ms
1.6 ms
1.6 ms
0.5, 1, 1.5, …, 4, 5, 6, 8 V
6V
6V
6V
0.03, 0.06, 0.1, 0.2, …,
1.6 ms
1.6 ms
1.6 ms
1.6 ms
Enable
On, Off
Off
On
Off
A. Detect Rate
120, 125, …, 175 bpm
175 bpm
175 bpm
175 bpm
V. Amplitude
V. Pulse Width
Mode Switch Parameters
Rate Response Pacing Parameters
Rate Response
1, 2, …, 10
Activity Threshold
Low, Medium Low, Medium
High, High
Medium Low
Medium Low
Medium
Low
Activity Acceleration
15, 30, 60 s
30 s
30 s
30 s
Activity Deceleration
Exercise, 2.5, 5, 10 min
5 min
5 min
5 min
Rate Adaptive AV Parameters
Enable
On, Off
On
On
On
Start Rate
50, 55, …, 145 bpm
60 bpm
60 bpm
60 bpm
Stop Rate
55, 60, …, 150 bpm
120 bpm
120 bpm
120 bpm
Minimum PAV
30, 40, …, 350 ms
140 ms
140 ms
140 ms
Minimum SAV
30, 40, …, 350 ms
110 ms
110 ms
110 ms
On
Additional Pacing Features
Non-Comp Atrial Pacing
Enable
On, Off
On
On
Interval
200, 250, …, 400 ms
300 ms
300 ms
300 ms
Off, 30, 40, …, 80 bpm
Off
Off
Off
Single Chamber
Hysteresis
V. Rate Stabilization
V. Rate Stabilization
On, Off
Off
Off
Off
V. Rate Stabilization
Minimum Interval
500, 550, …, 900 ms
500 ms
500 ms
500 ms
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Table 20. Bradycardia pacing parameters (continued)
Parameter
Programmable values
Shipped
Nominal
Reset
50, 60, …, 400 ms
150 ms
150 ms
150 ms
PMT Intervention
On, Off
Off
Off
Off
PVC Response
On, Off
On
On
On
V. Safety Pacing
On, Off
On
On
On
V. Rate Stabilization
Interval Increment
PVAB is the minimum value that PVARP is shortened to, under sensor-varied PVARP operation. Atrial
events that fall within the PVAB are ignored by the Mode Switch, NCAP, PVC Response, and PMT
Intervention features.
Peak pacing amplitude. When tested per CENELEC standard 45502-2-1, the measured
amplitude A depends upon the programmed amplitude Ap and programmed pulse width Wp:
A = Ap x [0.9 – (Wp x 0.145 ms-1)].
With a 40 ms sine2 waveform (ventricular sensitivity) or a 20 ms sine2 waveform (atrial sensitivity). When
using the CENELEC waveform, the rated sensing threshold value will be 1.5 times (ventricular) or 1.4
times (atrial) the rated sine2 sensing threshold.
This setting applies to all sensing in this chamber, for both tachyarrhythmia detection and bradycardia
pacing operations.
15.5.5 System maintenance parameters
Table 21. System maintenance parameters
Parameter
Programmable values
Shipped
Nominal
Reset
Automatic Capacitor
Formation Interval
Auto, 1, 2, …, 6 months
Auto a
Auto
Auto
Patient Alert time
enter time in hours and
minutes
8:00 am
—
8:00 am
Impedance patient alerts
A. Pacing lead
On, Off
Off
On
Off
Minimum Threshold
200, 300, 400, 500
200
200
200
Maximum Threshold
1000, 1500, 2000, 3000
3000
3000
3000
On, Off
Off
On
Off
Minimum Threshold
200, 300, 400, 500
200
200
200
Maximum Threshold
1000, 1500, 2000, 3000
3000
3000
3000
On, Off
Off
On
Off
Minimum Threshold
20, 30, 40, 50
20
20
20
Maximum Threshold
100, 130, 160, 200
200
200
200
On, Off
Off
On
Off
Minimum Threshold
20, 30, 40, 50
20
20
20
Maximum Threshold
100, 130, 160, 200
200
—
200
200
—
V. Pacing lead
V. Defibrillation lead
SVC (HVX) Defibrillation
lead
Lead impedance alert
urgency
Low, High
Low
32
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Printing instructions: doc#xxxxxx; refer to ’Implant manuals’ row in the applicable table.
Table 21. System maintenance parameters (continued)
Parameter
Programmable values
Shipped
Nominal
Reset
Low Battery Voltage ERI
patient alert
Off, On-Low, On-High
Off
On-Low
Off
Excessive Charge Time
ERI patient alert
Off, On-Low, On-High
Off
On-Low
Off
Number of Shocks
Delivered in an Episode
patient alert
Off, On-Low, On-High
Off
On-Low
Off
1, 2, …, 6
All Therapies in a
Zone Exhausted for
an Episode patient alert
Off, On-Low, On-High
Off
On-Low
Off
VF Detection/Therapy
Off b
Off, On-High
On-High
On-High
On-High
Number of Shocks
threshold
Automatic Capacitor Formation is disabled until VF Detection is set to On for the first time.
When this alert is turned on, it does not sound when a magnet is applied unless VF detection or more
than two VF therapies are turned off.
15.5.6 Data collection parameters
Table 22. Data collection parameters
Parameter
Programmable values
Shipped
Nominal
Reset
EGM Channel 1
Source
Can to HVB, Can to Vring, Can
to Aring, Vtip to HVB, Vtip to
Vring, Atip to Vring, Atip to
Aring, Can to HVX, a HVB to
HVX a
Atip to
Aring
Atip to Aring
Atip to
Aring
EGM Channel 1
Range
±2, ±4, ±8, ±16 mV
±8 mV
±8 mV
±8 mV
EGM Channel 2
Source
Can to HVB, Can to Vring, Vtip
to HVB, Vtip to Vring, Can to
HVX, a HVB to HVX a
Vtip to
Vring
Vtip to Vring
Vtip to
Vring
EGM Channel 2
Range
±2, ±4, ±8, ±16 mV
±8 mV
±8 mV
±8 mV
Store EGM Channel
1? b
Yes, No
Yes
Yes
Yes
Store EGM Channel
Yes (fixed)
—
—
—
Store EGM during
charging?
Yes, No
Yes
Yes
Yes
Store EGM before
tachycardia starts?
Yes, No
No
No
No
(enter time and date)
—
—
—
Device Date/Time
33
198483001 C
Medtronic Confidential
Composed:xxxx-xx-xx 11:48
MedtronCRM
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ECO Market Release
DBL:xxxxxxxxxxx
Printing instructions: doc#xxxxxx; refer to ’Implant manuals’ row in the applicable table.
Table 22. Data collection parameters (continued)
Parameter
Programmable values
Shipped
Nominal
Reset
Premature Event
Threshold
56, 59, 62, 66, 69, …, 84, 88,
91, 94, 97%
69%
69%
69%
Holter Telemetry
Duration
Off, 0.5, 1, 2, 4, 8, 16, 24, 36,
46 hours
Off
Off
Off
An SVC lead must be present for this configuration.
Both channels are available as real-time telemetered signals, regardless of this setting.
The time stamp on episode records and other stored data is determined by the device’s date/time clock.
15.5.7 System test and EP study parameters
Table 23. System test and EP study parameters
Parameter
Selectable values
Default
Pacing threshold test parameters
Test Type
Pulse Width - Auto Dec, Manual
Pulse Width - Auto Dec
Chamber
Atrium, Ventricle
Ventricle
Mode (atrial test) a
AAI, DDI, DDD
DDD b
Mode (ventricular test) a
VVI, DDI, DDD
VVI b
Lower Rate
30, 35, …, 60, 70, 75, …, 150 ppm c
90 ppm
150 ms b
AV Delay
30, 40, …, 350 ms
V. Amplitude d
0.5, 1, …, 4, 5, 6 V
3 Vb
V. Pulse Width
0.03, 0.06, 0.1, 0.2, …, 1.6 ms
0.4 ms b
V. Pace Blanking
150, 160, …, 440 ms
200 ms b
A. Amplitude d
0.5, 1, …, 4, 5, 6 V
3 ms b
A. Pulse Width
0.03, 0.06, 0.1, 0.2, …, 1.6 ms
0.4 ms b
A. Pace Blanking
150, 160, …, 250 ms
200 ms b
PVARP
150, 160, …, 500 ms
310 ms b
EGM Amplitude test parameters
Mode e
ODO, AAI, VVI, DDI, DDD
—
AV Delay
30, 40, …, 350 ms
Lower Rate
30, 35, …, 60, 70, 75, …, 120 ppm b
250 ms
—
#S1
2, 3, …, 8
S1S1
300, 310, …, 2000 ms
400 ms
Delay
50, 60, …, 600 ms
310 ms
Energy
0.4, 0.6, …, 1.8, 2, 3, …, 16, 18,
20, …, 30 J
0.6 J
Pathway
AX>B, B>AX
AX>B
Waveform
Monophasic, Biphasic
Pulse Amplitude d
8 V (fixed)
Monophasic
—
T-Shock induction parameters
34
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ECO Market Release
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Printing instructions: doc#xxxxxx; refer to ’Implant manuals’ row in the applicable table.
Table 23. System test and EP study parameters (continued)
Parameter
Selectable values
Pulse Width
1.6 ms (fixed)
Default
—
Enable
Enabled, Disabled
Disabled
Resume at Deliver
Enabled, Disabled
Enabled
50 Hz Burst Induction Parameters
Interval
20 ms (fixed)
—
Pulse Amplitude d
0.5, 1, …, 4, 5, 6, 8 V
8V
Pulse Width
0.03, 0.06, 0.1, 0.2, …, 1.6 ms
1.6 ms
Resume at Burst
Enabled, Disabled
Enabled
Manual Burst Induction Parameters
Chamber
Ventricle, Atrium
Ventricle
Interval
100, 110, …, 600 ms
600 ms
Pulse Amplitude d
0.5, 1, …, 4, 5, 6, 8 V
4V
Pulse Width
0.03, 0.06, 0.1, 0.2, …, 1.6 ms
0.5 ms
Resume at Burst
Enabled, Disabled
Enabled
VVI Backup
On, Off
Off
VVI Backup Pacing Rate
30, 35, …, 120 ppm
60 ppm
VVI Backup Amplitude d
0.5, 1, …, 4, 5, 6 V
4 Vb
VVI Backup Pulse Width
0.03, 0.06, 0.1, 0.2, …,1.6 ms
0.5 ms b
Chamber
Ventricle, Atrium
Ventricle
#S1
1, 2, …, 15
S1S1
100, 110, …, 2000 ms
600 ms
S1S2
Off, 100, 110, …, 600 ms
400 ms
PES Induction Parameters
S2S3
Off, 100, 110, …, 600 ms
Off
S3S4
Off, 100, 110, …, 600 ms
Off
Pulse Amplitude d
0.5, 1, …, 4, 5, 6, 8 V
4V
Pulse Width
0.03, 0.06, 0.1, 0.2, …, 1.6 ms
0.5 ms
Resume at Deliver
Enabled, Disabled
Enabled
VVI Backup
On, Off
Off
VVI Backup Pacing Rate
30, 35, …, 120 ppm
60 ppm
VVI Backup Amplitude d
0.5, 1, …, 4, 5, 6 V
4 Vb
VVI Backup Pulse Width
0.03, 0.06, 0.1, 0.2, …,1.6 ms
0.5 ms b
35
198483001 C
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MedtronCRM
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ECO Market Release
DBL:xxxxxxxxxxx
Printing instructions: doc#xxxxxx; refer to ’Implant manuals’ row in the applicable table.
Table 23. System test and EP study parameters (continued)
Parameter
Selectable values
Default
Manual therapy parameters
In general, each manual therapy provides the same parameter values as the automatic therapy. See
Table 19.
The selectable values for this parameter depend on the programmed pacing mode.
The default value for this parameter is set according to the permanently programmed settings for
bradycardia pacing if the device has been interrogated. Otherwise it defaults to the indicated nominal
value.
The maximum range value is dependant on the programmed pacing mode.
Peak pacing amplitude. When tested per CENELEC standard 45502-2-1, the measured
amplitude A depends upon the programmed amplitude Ap and programmed pulse width Wp:
A = Ap x [0.9 – (Wp x 0.145 ms-1)].
Delivered energy based on a biphasic pulse into a 75 load. For energy less than 1 J, tolerance
is ±0.25 J.
15.5.8 Fixed parameters
Table 24. Fixed parameters
Parameter
Fixed value
Fixed blanking periods
Atrial blanking after a sensed atrial event
100 ms
Atrial blanking after a paced ventricular event
30 ms
Atrial blanking after high voltage therapy
520 ms
Ventricular blanking after a sensed ventricular event
120 ms
Ventricular blanking after a paced atrial event
30 ms
Ventricular blanking on a high voltage pulse delivery
520 ms
Fixed bradycardia pacing parameters
110 ms, 70 ms a
Ventricular Safety Pacing intervals
PVC Response (PVARP extension)
Extended to 400 ms b
PMT Intervention (PVARP extension)
Extended to 400 ms b
Fixed high voltage therapy parameters
Maximum charging period
30 s
Waveform
Biphasic
Tilt
50%
Refractory period after V-sense during cardioversion
synchronization
200 ms
Refractory period after charge end
100 ms
Refractory period after paced event during charging
or synchronization c
400 ms
Refractory period after charge begins c
400 ms
Atrial Vulnerable Period
250 ms
Escape interval after high voltage therapy
1200 ms
36
198483001 C
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ECO Market Release
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Printing instructions: doc#xxxxxx; refer to ’Implant manuals’ row in the applicable table.
Table 24. Fixed parameters (continued)
Parameter
Fixed value
Suspension of VT detection after defibrillation therapy
17 V. events
Fixed EP Study parameters
T-Shock pacing amplitude d
8V
T-Shock pacing pulse width
1.6 ms
50 Hz burst pacing interval
20 ms
Hardware parameters
Atrial rate limit (protective feature)
171 ppm e
Ventricular rate limit (protective feature)
171 ppm e
Input impedance
100 k
minimum
The shorter VSP interval takes effect when the pacing rate exceeds the results of the following formula:
60000 / 2 x (Ventricular Pace Blanking + 110) per min.
PVARP is only extended to 400 ms if the current PVARP (either the programmed PVARP value or the
current Sensor-Varied PVARP value) is less than 400 ms.
Does not affect event classification during charging.
Peak pacing amplitude. When tested per CENELEC standard 45502-2-1, the measured
amplitude A depends upon the programmed amplitude Ap and programmed pulse width Wp:
A = Ap x [0.9 – (Wp x 0.145 ms-1)].
Does not apply during therapies, programmed high rates, or ventricular safety pacing.
37
198483001 C
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FCC REGULATORY LABELING REQUIREMENTS
The transmitter covered by this manual has been certified under FCC ID:LF5MICSIMPLANT.
This transmitter is authorized by rule under the Medical Implant Communications Service (47
C.F.R. Part 95) and must not cause harmful interference to stations operating in the 400.150 406.000 MHz band in the Meteorological Aids (i.e. transmitters and receivers used to
communicate weather data), the Meteorological Satellite, or the Earth Exploration Satellite
Services and must accept interference that may be caused by such aids, including interference that
may cause undesired operation. This transmitter shall be used only in accordance with the FCC
Rules governing the Medical Implant Communications Service. Analog and digital voice
communications are prohibited. Although this transmitter has been approved by the Federal
Communications Commission, there is no guarantee that it will not receive interference or that
any particular transmission from this transmitter will be free from interference.
This device may not interfere with stations operating in the 400.150 - 406.000 MHz band in the
Meteorological Aids, Meteorological Satellite, and Earth Exploration Satellite Services and must
accept any interference received, including interference that may cause undesired operation.
ECO Market Release
DBL:xxxx-xx-xx
Printing instructions: doc#xxxxxx; refer to ’Implant manuals’ row in the applicable table.
World Headquarters
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432-5604
USA
Internet: www.medtronic.com
Tel. 763-514-4000
Fax 763-514-4879
Canada
Medtronic of Canada Ltd.
6733 Kitimat Road
Mississauga, Ontario L5N 1W3
Tel. 905-826-6020
Fax 905-826-6620
Toll-free in Canada: 1-800-268-5346
Europe/Africa/Middle East
Headquarters
Medtronic Europe S.A.
Route du Molliau
CH-1131 Tolochenaz
Switzerland
Internet: www.medtronic.co.uk
Tel. 41-21-802-7000
Fax 41-21-802-7900
*198483001*
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Medtronic E.C. Authorized
Representative/Distributed by
Medtronic B.V.
Wenckebachstraat 10
6466 NC Kerkrade
The Netherlands
Tel. 31-45-566-8000
Fax 31-45-566-8668
Japan
Medtronic Japan
Solid Square West Tower 6F,
580 Horikawa-cho, Saiwai-ku
Kawasaki, Kanagawa 210-0913
Japan
Tel. 81-44-540-6112
Fax 81-44-540-6200
Asia
Medtronic International Ltd.
Suite 1602 16/F, Manulife Plaza
The Lee Gardens, 33 Hysan Avenue
Causeway Bay, Hong Kong
Tel. 852-2891-4068
Fax 852-2591-0313
Australia
Medtronic Australasia Pty. Ltd.
Unit 4/446 Victoria Road
Gladesville NSW 2111
Australia
Tel. 61-2-9879-5999
Fax 61-2-9879-5100
© Medtronic, Inc. 2002
UCX198483001
198483001
2002-02-14
Composed:xxxx-xx-xx 11:48
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