Boston Scientific CRMV17311 K172, K173, K174, K175, K176, K177, K062, K063, K064, K065, K066, K067, K272, K 273, K274, K275, K276, K277, V272, V273, V172, V173, K278, K279 User Manual wrench rotation side

Boston Scientific Corporation K172, K173, K174, K175, K176, K177, K062, K063, K064, K065, K066, K067, K272, K 273, K274, K275, K276, K277, V272, V273, V172, V173, K278, K279 wrench rotation side

User Manual

PHYSICIAN’S TECHNICAL MANUALINGENIO™PACEMAKERModel K172, K173, K174CAUTION: Federal law (USA)restricts this device to sale byor on the order of a physiciantrained or experienced indevice implant and follow-upprocedures.
Table of ContentsAdditional Technical Information................................................................................. 1Device Description...................................................................................................... 1Related Information .................................................................................................... 3Indications and Usage ................................................................................................ 3Contraindications........................................................................................................ 5Warnings .................................................................................................................... 6Precautions................................................................................................................. 8Supplemental Precautionary Information ................................................................. 27Post-Therapy Pulse Generator Follow Up........................................................ 27Transcutaneous Electrical Nerve Stimulation (TENS)...................................... 29Electrocautery and Radio Frequency (RF) Ablation......................................... 31Ionizing Radiation............................................................................................. 33Elevated Pressures .......................................................................................... 34Potential Adverse Events ......................................................................................... 37Mechanical Specifications ........................................................................................ 39Items Included in Package ....................................................................................... 41Symbols on Packaging ............................................................................................. 42Characteristics as Shipped....................................................................................... 45X-Ray Identifier......................................................................................................... 47Federal Communications Commission (FCC) .......................................................... 48Pulse Generator Longevity ....................................................................................... 49Warranty Information ................................................................................................ 55
Product Reliability..................................................................................................... 55Patient Counseling Information ................................................................................ 56Patient Handbook............................................................................................. 57Lead Connections..................................................................................................... 58Implanting the Pulse Generator................................................................................ 59Step A: Check Equipment.............................................................................. 60Step B: Interrogate and Check the Pulse Generator ..................................... 60Step C: Implant the Lead System .................................................................. 61Step D: Take Baseline Measurements........................................................... 62Step E: Form the Implantation Pocket ........................................................... 64Step F: Connect the Leads to the Pulse Generator....................................... 66Step G: Evaluate Lead Signals...................................................................... 71Step H: Program the Pulse Generator ........................................................... 72Step I: Implant the Pulse Generator .............................................................. 72Step J: Complete and Return the Implantation Form .................................... 73Bidirectional Torque Wrench..................................................................................... 74Follow Up Testing ..................................................................................................... 76Predischarge Follow Up ................................................................................... 77Routine Follow Up ............................................................................................ 77Explantation.............................................................................................................. 79
ADDITIONAL TECHNICAL INFORMATIONFor additional technical reference guides, go to www.bostonscientific.com/ifu.Boston Scientific Corporation acquired Guidant Corporation in April 2006. Duringour transition period, you may see both the Boston Scientific and Guidant names onproduct and patient material. As we work through the transition, we will continue tooffer doctors and their patients technologically advanced and high quality medicaldevices and therapies.DEVICE DESCRIPTIONThis manual contains information about the INGENIO family of implantablepacemakers, including the following types of pulse generators (specific models arelisted in "Mechanical Specifications" on page 39):• SR—single chamber pacemaker providing ventricular or atrial pacing and sensing• DR—dual-chamber pacemaker providing ventricular and atrial pacing and sensingTherapiesThese pulse generators provide bradycardia pacing and adaptive rate pacing to detectand treat bradyarrhythmias.1
LeadsThe pulse generator has independently programmable outputs and accepts one ormore of the following leads, depending on the model:•OneIS-11unipolar or bipolar atrial lead• One IS-1 unipolar or bipolar right ventricular leadNOTE: Single-chamber devices will accept either an IS-1 atrial or an IS-1ventricular lead.The pulse generator and the leads constitute the implantable portion of the pulsegenerator system.PRM SystemThese pulse generators can be used only with the ZOOM LATITUDE ProgrammingSystem, which is the external portion of the pulse generator system and includes:• Model 3120 Programmer/Recorder/Monitor (PRM)• Model 2869 ZOOMVIEW Software Application• Model 6577 Accessory Telemetry Wand1. IS-1 refers to the international standard ISO 5841-3:2000.2
You can use the PRM system to do the following:• Interrogate the pulse generator• Program the pulse generator to provide a variety of therapy options• Access the pulse generator’s diagnostic features• Perform noninvasive diagnostic testing• Access therapy history dataRELATED INFORMATIONRefer to the lead’s instruction manual for implant information, general warningsand precautions, indications, contraindications, and technical specifications. Readthis material carefully for implant procedure instructions specific to the chosen leadconfigurations.Refer to the PRM system Operator’s Manual for specific information about the PRMsuch as setup, maintenance, and handling.INDICATIONS AND USAGEBoston Scientific pacemakers are indicated for treatment of the following conditions:• Symptomatic paroxysmal or permanent second- or third-degree AV block• Symptomatic bilateral bundle branch block3
• Symptomatic paroxysmal or transient sinus node dysfunction with or withoutassociated AV conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial[SA] block• Bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or someforms of symptomatic tachyarrhythmias• Neurovascular (vaso-vagal) syndromes or hypersensitive carotid sinus syndromesAdaptive-rate pacing is indicated for patients exhibiting chronotropic incompetence andwho may benefit from increased pacing rates concurrent with increases in minuteventilation and/or level of physical activity.Dual-chamber and atrial tracking modes are also indicated for patients who may benefitfrom maintenance of AV synchrony.Dual chamber modes are specifically indicated for treatment of the following:• Conduction disorders that require restoration of AV synchrony, including varyingdegrees of AV block• VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinusrhythm• Low cardiac output or congestive heart failure secondary to bradycardia4
CONTRAINDICATIONSThese Boston Scientific pacemakers are contraindicated in patients who have aseparate implanted cardioverter-defibrillator (ICD).Use of certain pacing modes and/or features available in these Boston Scientificpacemakers is contraindicated for the following patients under the circumstances listed:• Minute ventilation in patients with both unipolar atrial and ventricular leads• Single-chamber atrial pacing in patients with impaired AV nodal conduction• Atrial tracking modes for patients with chronic refractory atrial tachyarrhythmias(atrial fibrillation or flutter), which might trigger ventricular pacing• Dual-chamber and single-chamber atrial pacing in patients with chronic refractoryatrial tachyarrhythmias• Asynchronous pacing in the presence (or likelihood) of competition betweenpaced and intrinsic rhythms5
WARNINGSGeneral• Labeling knowledge. Read this manual thoroughly before implantation to avoiddamage to the pulse generator and/or lead. Such damage can result in patientinjury or death.• For single patient use only. Do not reuse, reprocess, or resterilize. Reuse,reprocessing, or resterilization may compromise the structural integrity of thedevice and/or lead to device failure which, in turn, may result in patient injury,illness, or death. Reuse, reprocessing, or resterilization may also create a riskof contamination of the device and/or cause patient infection or cross-infection,including, but not limited to, the transmission of infectious disease(s) from onepatient to another. Contamination of the device may lead to injury, illness, ordeath of the patient.• Backup defibrillation protection. Always have external defibrillation protectionavailable during implant and electrophysiologic testing. If not terminated in a timelyfashion, an induced ventricular tachyarrhythmia can result in the patient’s death.• Separate pulse generator. Do not use this pulse generator with another pulsegenerator. This combination could cause pulse generator interaction, resulting inpatient injury or a lack of therapy delivery.6
• Safety Core operation. In response to applicable nonrecoverable or repeat faultconditions, the pulse generator will switch irreversibly to Safety Core operation.Safety Core pacing is unipolar, which is contraindicated for patients with an ICD.Handling• Do not kink leads. Do not kink, twist, or braid the lead with other leads as doingso could cause lead insulation abrasion damage or conductor damage.Programming and Device Operations• Atrial tracking modes. Do not use atrial tracking modes in patients with chronicrefractory atrial tachyarrhythmias. Tracking of atrial arrhythmias could result inventricular tachyarrhythmias.• Lead safety switch programmed to On. In devices with the lead safety switchprogrammed to On, the lead polarity will switch to unipolar in the presence of alead impedance of ≤200 or ≥2000 Ω. Unipolar pacing is contraindicated forpatients with an ICD.• Sensitivity settings and EMI. If programmed to a fixed atrial sensitivity valueof 0.15 mV, the pulse generator may be more susceptible to electromagneticinterference. This increased susceptibility should be taken into considerationwhen determining the follow-up schedule for patients requiring such a setting.7
Post-Implant• Protected environments. Advise patients to seek medical guidance beforeentering environments that could adversely affect the operation of the activeimplantable medical device, including areas protected by a warning notice thatprevents entry by patients who have a pulse generator.• Magnetic Resonance Imaging (MRI) exposure. Do not expose a patient to MRIscanning. Strong magnetic fields may damage the pulse generator and/or leadsystem, possibly resulting in injury to or death of the patient.• Diathermy. Do not subject a patient with an implanted pulse generator and/or leadto diathermy since diathermy may cause fibrillation, burning of the myocardium,and irreversible damage to the pulse generator because of induced currents.PRECAUTIONSClinical Considerations•STATPACE.STAT PACE will initiate unipolar pacing.• Pacemaker-mediated tachycardia (PMT). Programming minimum PVARP lessthan retrograde V–A conduction may increase the likelihood of a PMT.• Automatic Capture. Automatic Capture is intended for ventricular use only. Donot program Amplitude to Auto for single-chamber devices implanted in the atrium.8
• MV sensor modes. The safety and efficacy of the MV sensor modes have notbeen clinically established in patients with abdominal implant sites.• MV sensor mode performance. MV sensor performance may be adverselyaffected under transient conditions such as pneumothorax, pericardial effusion, orpleural effusion. Consider programming the MV sensor Off until these conditionsare resolved.9
• Adaptive-rate modes. Adaptive-rate modes based completely or in part on MVmight be inappropriate for patients who can achieve respiratory cycles shorterthan one second (greater than 60 breaths per minute). Higher respiration ratesattenuate the impedance signal, which diminishes the MV rate response (i.e., thepacing rate will drop toward the programmed LRL).Adaptive-rate modes based completely or in part on MV should not be used forpatients with:•AnICD• Unipolar leads—for MV detection, a bipolar lead is required in either theatrium or ventricle• Epicardial ventricular leads—MV measurement has only been tested witha bipolar transvenous lead• A mechanical ventilator—use of the ventilator might result in an inappropriateMV sensor-driven rate10
Sterilization and Storage• If package is damaged. The blister trays and contents are sterilized withethylene oxide gas before final packaging. When the pulse generator and/or leadis received, it is sterile provided the container is intact. If the packaging is wet,punctured, opened, or otherwise damaged, return the pulse generator and/orlead to Boston Scientific.• Storage temperature and equilibration. Recommended storage temperaturesare 0°C–50°C (32°F–122°F). Allow the device to reach a proper temperaturebefore using telemetry communication capabilities, programming or implanting thedevice because temperature extremes may affect initial device function.• Device storage. Store the pulse generator in a clean area away from magnets,kits containing magnets, and sources of EMI to avoid device damage.•Usebydate.Implant the pulse generator and/or lead before or on the USE BYdate on the package label because this date reflects a validated shelf life. Forexample, if the date is January 1, do not implant on or after January 2.Implantation• Expected benefits. Determine whether the expected device benefits provided byprogrammable options outweigh the possibility of more rapid battery depletion.11
• Evaluate patient for surgery. There may be additional factors regarding thepatient’s overall health and medical condition that, while not related to devicefunction or purpose, could render the patient a poor candidate for implantation ofthis system. Cardiac health advocacy groups may have published guidelines thatmay be helpful in conducting this evaluation.• Lead compatibility. Prior to implantation, confirm the lead-to-pulse generatorcompatibility. Using incompatible leads and pulse generators can damage theconnector and/or result in potential adverse consequences, such as undersensingof cardiac activity or failure to deliver necessary therapy.• Telemetry wand. Make sure a sterile telemetry wand is available should lossof ZIP telemetry occur. Verify that the wand can easily be connected to theprogrammer and is within reach of the pulse generator.• Line-powered equipment. Exercise extreme caution if testing leads usingline-powered equipment because leakage current exceeding 10 µA can induceventricular fibrillation. Ensure that any line-powered equipment is withinspecifications.12
• Replacement device. Implanting a replacement device in a subcutaneous pocketthat previously housed a larger device may result in pocket air entrapment,migration, erosion, or insufficient grounding between the device and tissue.Irrigating the pocket with sterile saline solution decreases the possibility of pocketair entrapment and insufficient grounding. Suturing the device in place reducesthe possibility of migration and erosion.• Do not bend the lead near the lead-header interface. Insert the lead terminalstraight into the lead port. Do not bend the lead near the lead-header interface.Improper insertion can cause insulation or connector damage.• Absence of a lead. The absence of a lead or plug in a lead port may affectdevice performance. If a lead is not used, be sure to properly insert a plug in theunused port, and then tighten the setscrew onto the plug.• Dual chamber device without a functional RV lead. If a dual-chamberdevice is programmed to AAI(R), ensure that a functional RV lead is present.In the absence of a functional RV lead, programming to AAI(R) may result inundersensing or oversensing.13
• Electrode connections. Do not insert a lead into the pulse generator connectorwithout taking the following precautions to ensure proper lead insertion:• Insert the torque wrench into the preslit depression of the seal plug beforeinserting the lead into the port, to release any trapped fluid or air.• Visually verify that the setscrew is sufficiently retracted to allow insertion.Use the torque wrench to loosen the setscrew if necessary.• Fully insert each lead into its lead port and then tighten the setscrew ontothe terminal pin.• Shunting energy. Do not allow any object that is electrically conductive to comeinto contact with the lead or device during induction because it may shunt energy,resulting in less energy getting to the patient, and may damage the implantedsystem.• Do not suture directly over lead. Do not suture directly over the lead body, asthis may cause structural damage. Use the suture sleeve to secure the leadproximal to the venous entry site to prevent lead movement.• MV Sensor. Do not program the MV sensor to On until after the pulse generatorhas been implanted and system integrity has been tested and verified.14
Device Programming• Device communication. Use only the designated PRM and software applicationto communicate with this pulse generator.• STAT PACE settings. When a pulse generator is programmed to STAT PACEsettings, it will continue to pace at the high-energy STAT PACE values if it is notreprogrammed. The use of STAT PACE parameters will likely decrease devicelongevity.• Pacing and sensing margins. Consider lead maturation in your choice of pacingamplitude, pacing pulse width, and sensitivity settings.• An acute pacing threshold greater than 1.5 V or a chronic pacing thresholdgreater than 3 V can result in loss of capture because thresholds mayincrease over time.• An R-wave amplitude less than 5 mV or a P-wave amplitude less than 2 mVcan result in undersensing because the sensed amplitude may decreaseafter implantation.• Pacing lead impedance should be within the range of 200 Ωand 2000 Ω.• Lead impedance values and Lead Safety Switch. If leads with measuredimpedance values approaching 200 or 2000 Ωare used, consider programmingLead Safety Switch Off.15
• Proper programming of the lead configuration. If the Lead Configuration isprogrammed to Bipolar when a unipolar lead is implanted, pacing will not occur.• Programming for supraventricular tachyarrhythmias (SVTs). Determine if thedevice and programmable options are appropriate for patients with SVTs becauseSVTs can initiate unwanted device therapy.• Adaptive-rate pacing. Rate adaptive pacing should be used with care in patientswho are unable to tolerate increased pacing rates.• Ventricular refractory periods (VRPs) in adaptive-rate pacing. Adaptive-ratepacing is not limited by refractory periods. A long refractory period programmed incombination with a high MSR can result in asynchronous pacing during refractoryperiods since the combination can cause a very small sensing window or none atall. Use dynamic AV Delay or dynamic PVARP to optimize sensing windows. Ifyou are entering a fixed AV delay, consider the sensing outcomes.• Atrial oversensing. Take care to ensure that artifacts from the ventricles arenot present on the atrial channel, or atrial oversensing may result. If ventricularartifacts are present in the atrial channel, the atrial lead may need to berepositioned to minimize its interaction.16
• ATR entry count. Exercise care when programming the Entry Count to lowvalues in conjunction with a short ATR Duration. This combination allows modeswitching with very few fast atrial beats. For example, if the Entry Count wasprogrammed to 2 and the ATR Duration to 0, ATR mode switching could occur on2 fast atrial intervals. In these instances, a short series of premature atrial eventscould cause the device to mode switch.• ATR exit count. Exercise care when programming the Exit Count to low values.For example, if the Exit Count was programmed to 2, a few cycles of atrialundersensing could cause termination of mode switching.• Proper programming without an atrial lead. If an atrial lead is not implanted(port is plugged instead), or an atrial lead is abandoned but remains connectedto the header, device programming should be consistent with the number andtype of leads actually in use.• MV Recalibration. To obtain an accurate MV baseline, the MV sensor will becalibrated automatically or can be calibrated manually. A new, manual calibrationshould be performed if the pulse generator is removed from the pocket followingimplant, such as during a lead repositioning procedure, or in cases where theMV baseline may have been affected by factors such as lead maturation, airentrapment in the pocket, pulse generator motion due to inadequate suturing,external defibrillation or cardioversion, or other patient complications (e.g.,pneumothorax).17
• Sensing adjustment. Following any Sensitivity parameter adjustment or anymodification of the sensing lead, always verify appropriate sensing. ProgrammingSensitivity to the highest value (lowest sensitivity) may result in undersensing ofcardiac activity. Likewise, programming to the lowest value (highest sensitivity)may result in oversensing of non-cardiac signals.• Sensitivity in unipolar lead configuraton. The amplitude and prevalence ofmyopotential noise is increased in unipolar lead configurations, as comparedto bipolar lead configurations. For patients with a unipolar lead configurationand myopotential oversensing during activity involving the pectoral muscles, theprogramming of Fixed Sensitivity is recommended.Environmental and Medical Therapy Hazards• Avoid electromagnetic interference (EMI). Advise patients to avoid sources ofEMI. The pulse generator may inhibit pacing due to oversensing, or may switchto asynchronous pacing at the programmed pacing rate or at the magnet rate inthepresenceofEMI.Moving away from the source of the EMI or turning off the source usually allowsthe pulse generator to return to normal operation.18
Examples of potential EMI sources are:• Electrical power sources, arc welding or resistance welding equipment, androbotic jacks• High voltage power distribution lines• Electrical smelting furnaces• Large RF transmitters such as radar• Radio transmitters, including those used to control toys• Electronic surveillance (antitheft) devices• An alternator on a car that is running• Medical treatments and diagnostic tests in which an electricalcurrent is passed through the body, such as TENS, electrocautery,electrolysis/thermolysis, electrodiagnostic testing, electromyography, ornerve conduction studies• Any externally applied device that uses an automatic lead detection alarmsystem (e.g., an EKG machine)19
Hospital and Medical Environments• Mechanical ventilators.Program the MV Sensor to Off during mechanical ventilation. Otherwise, the followingmay occur:• Inappropriate MV sensor-driven rate• Misleading respiration-based trending• Conducted electrical current. Any medical equipment, treatment, therapy, ordiagnostic test that introduces electrical current into the patient has the potentialto interfere with pulse generator function.• External patient monitors (e.g., respiratory monitors, surface ECGmonitors, hemodynamic monitors) may interfere with the pulse generator’simpedance-based diagnostics (e.g., Respiratory Rate trend). Thisinterference may also result in accelerated pacing, possibly up to themaximum sensor-driven rate, when MV is programmed to On. To resolvesuspected interactions, deactivate the MV sensor either by programming it toOff (no MV rate driving or MV sensor-based trending will occur), or Passive(no MV rate driving will occur). Alternatively, program the Brady Mode to anon-rate responsive mode (no MV rate driving will occur). If a PRM is notavailable and the pulse generator is pacing at the sensor-driven rate, apply a20
magnet to the pulse generator to initiate temporary asynchronous, non-rateresponsive pacing.• Medical therapies, treatments, and diagnostic tests that use conductedelectrical current (e.g., TENS, electrocautery, electrolysis/thermolysis,electrodiagnostic testing, electromyography, or nerve conduction studies)may interfere with or damage the pulse generator. Program the device toElectrocautery Mode prior to the treatment, and monitor device performanceduring the treatment. After the treatment, verify pulse generator function("Post-Therapy Pulse Generator Follow Up" on page 27).• Internal defibrillation. Do not use internal defibrillation paddles or cathetersunless the pulse generator is disconnected from the leads because the leadsmay shunt energy. This could result in injury to the patient and damage to theimplanted system.21
• External defibrillation. It can take up to 15 seconds for sensing to recoverafter an external shock is delivered. In non-emergency situations, forpacemaker dependent patients, consider programming the pulse generator toan asynchronous pacing mode prior to performing external cardioversion ordefibrillation.External defibrillation or cardioversion can damage the pulse generator. To helpprevent damage to the pulse generator, consider the following:• Avoid placing a pad (or paddle) directly over the pulse generator. Positionthe pads (or paddles) as far from the pulse generator as possible.• Position the pads (or paddles) in a posterior-anterior orientation when thedevice is implanted in the right pectoral region or an anterior-apex orientationwhen the device is implanted in the left pectoral region.• Set energy output of external defibrillation equipment as low as clinicallyacceptable.• In non-emergency situations, prior to performing external cardioversion ordefibrillation, program the MV sensor to Off.Following external cardioversion or defibrillation, verify pulse generator function("Post-Therapy Pulse Generator Follow Up" on page 27).22
•Lithotripsy.Extracorporeal shock wave lithotripsy (ESWL) may causeelectromagnetic interference with or damage to the pulse generator. If ESWLis medically necessary, consider the following to minimize the potential forencountering interaction:• Focus the ESWL beam at least 15 cm (6 in) away from the pulse generator.• Depending on the pacing needs of the patient, program the Brady Mode to anon-rate-responsive VVI or VOO mode.• Ultrasound energy. Therapeutic ultrasound (e.g., lithotripsy) energy may damagethe pulse generator. If therapeutic ultrasound energy must be used, avoid focusingnear the pulse generator site. Diagnostic ultrasound (e.g., echocardiography) isnot known to be harmful to the pulse generator.• Electrical interference. Electrical interference or “noise” from devices suchas electrocautery and monitoring equipment may interfere with establishing ormaintaining telemetry for interrogating or programming the device. In the presenceof such interference, move the programmer away from electrical devices, andensure that the wand cord and cables are not crossing one another. If telemetry iscancelled as a result of interference, the device should be re-interrogated prior toevaluating information from pulse generator memory.23
• Radio frequency (RF) interference. RF signals from devices that operate atfrequencies near that of the pulse generator may interrupt ZIP telemetry whileinterrogating or programming the pulse generator. This RF interference can bereduced by increasing the distance between the interfering device and the PRMand pulse generator. Examples of devices that may cause interference include:• Cordless phone handsets or base stations• Certain patient monitoring systems• Central line guidewire insertion. Use caution when inserting guidewires forplacement of other types of central venous catheter systems such as PIC lines orHickman catheters in locations where pulse generator leads may be encountered.Insertion of such guidewires into veins containing leads could result in the leadsbeing damaged or dislodged.Home and Occupational Environments• Home appliances. Home appliances that are in good working order and properlygrounded do not usually produce enough EMI to interfere with pulse generatoroperation. There have been reports of pulse generator disturbances causedby electric hand tools or electric razors used directly over the pulse generatorimplant site.24
• Magnetic fields. Advise patients that extended exposure to strong (greater than10 gauss or 1 mTesla) magnetic fields may trigger the magnet feature. Examplesof magnetic sources include:• Industrial transformers and motors• MRI scanners• Large stereo speakers• Telephone receivers if held within 1.27 cm (0.5 inches) of the pulse generator• Magnetic wands such as those used for airport security and in the Bingogame• Electronic Article Surveillance (EAS). Advise patients to avoid lingering nearantitheft devices such as those found in the entrances and exits of departmentstores and public libraries. Patients should walk through them at a normal pacebecause such devices may cause inappropriate pulse generator operation.• Cellular phones. Advise patients to hold cellular phones to the ear opposite theside of the implanted device. Patients should not carry a cellular phone that isturned on in a breast pocket or on a belt within 15 cm (6 inches) of the implanteddevice since some cellular phones may cause the pulse generator to deliverinappropriate therapy or inhibit appropriate therapy.25
Follow-up Testing• Pacing threshold testing. If the patient’s condition or drug regimen has changedor device parameters have been reprogrammed, consider performing a pacingthreshold test to confirm adequate margins for pace capture.• Follow-up considerations for patients leaving the country. Pulse generatorfollow-up considerations should be made in advance for patients who plan totravel or relocate post-implant to a country other than the country in which theirdevice was implanted. Regulatory approval status for devices and associatedprogrammer software configurations varies by country; certain countries may nothave approval or capability to follow specific products.Contact Boston Scientific, using the information on the back cover, for help indetermining feasibility of device follow-up in the patient’s destination country.Explant and Disposal• Incineration. Be sure that the pulse generator is removed before cremation.Cremation and incineration temperatures might cause the pulse generator toexplode.26
• Device handling. Before explanting, cleaning, or shipping the device, completethe following actions to prevent overwriting of important therapy history data:• Program the pulse generator Brady Mode to Off• Program Ventricular Tachy EGM Storage to OffClean and disinfect the device using standard biohazard handling techniques.• Explanted devices. Return all explanted pulse generators and leads toBoston Scientific. Examination of explanted pulse generators and leads canprovide information for continued improvement in system reliability and warrantyconsiderations.Do not implant an explanted pulse generator and/or lead in another patient assterility, functionality, and reliability cannot be ensured.SUPPLEMENTAL PRECAUTIONARY INFORMATIONPost-Therapy Pulse Generator Follow UpFollowing any surgery or medical procedure with the potential to affect pulse generatorfunction, you should perform a thorough follow-up, which may include the following:• Interrogating the pulse generator with a programmer• Reviewing clinical events and fault codes27
• Reviewing the Arrhythmia Logbook, including stored electrograms (EGMs)• Reviewing real-time EGMs• Testing the leads (threshold, amplitude, and impedance)• Reviewing MV sensor-based diagnostics, MV sensor performance, andperforming a manual MV sensor calibration if desired• Verifying battery status• Programming any permanent brady parameter to a new value and thenreprogramming it back to the desired value• Saving all patient data• Verifying the appropriate final programming prior to allowing the patient to leavethe clinic28
Transcutaneous Electrical Nerve Stimulation (TENS)CAUTION: TENS involves passing electrical current through the body, and mayinterfere with pulse generator function. If TENS is medically necessary, evaluatethe TENS therapy settings for compatibility with the pulse generator. The followingguidelines may reduce the likelihood of interaction:• Place the TENS electrodes as close together and as far away from the pulsegenerator and leads as possible.• Use the lowest clinically-appropriate TENS energy output.• Consider cardiac monitoring during TENS use, especially forpacemaker-dependent patients.Additional steps can be taken to help reduce interference during in-clinic use of TENS:• If interference is suspected during in-clinic use, turn off the TENS unit.• If pacing inhibition is observed, use a magnet to pace asynchronously.• Do not change TENS settings until you have verified that the new settings do notinterfere with pulse generator function.29
If TENS is medically necessary outside the clinical setting (at-home use), providepatients with the following instructions:• Do not change the TENS settings or electrode positions unless instructed to do so.• End each TENS session by turning off the unit before removing the electrodes.• If the patient experiences symptoms of lightheadedness, dizziness, or loss ofconsciousness during TENS use, they should turn off the TENS unit and contacttheir physician.Follow these steps to use the PRM to evaluate pulse generator function during TENSuse:1. Observe real-time EGMs at prescribed TENS output settings, noting whenappropriate sensing or interference occurs.NOTE: Patient triggered monitoring may be used as an additional method to confirmdevice function during TENS use.2. When finished, turn off the TENS unit.You should also perform a thorough follow-up evaluation of the pulse generatorfollowing TENS, to ensure that device function has not been compromised("Post-Therapy Pulse Generator Follow Up" on page 27).30
For additional information, contact Boston Scientific using the information on the backcover.Electrocautery and Radio Frequency (RF) AblationCAUTION: Electrocautery and RF ablation may induce ventricular arrhythmiasand/or fibrillation, and may cause asynchronous pacing, inhibition of pacing and/or areduction in pulse generator pacing output possibly leading to loss of capture. RFablation may also cause ventricular pacing up to the MTR and/or changes in pacingthresholds. Additionally, exercise caution when performing any other type of cardiacablation procedure in patients with implanted devices.If electrocautery or RF ablation is medically necessary, observe the following tominimize risk to the patient and device:• Depending on the pacing needs of the patient, enable the ElectrocauteryProtection Mode, program to an asynchronous pacing mode, or use a magnetto switch to asynchronous pacing. An option for patients with intrinsic rhythmis to program the Brady Mode to VVI at a rate below the intrinsic rate to avoidcompetitive pacing.• Have temporary pacing and external defibrillation equipment available.31
• Avoid direct contact between the electrocautery equipment or ablation cathetersand the pulse generator and leads. RF ablation close to the lead electrode maydamage the lead-tissue interface.• Keep the path of the electrical current as far away as possible from the pulsegenerator and leads.• If RF ablation and/or electrocautery is performed on tissue near the device orleads, monitor pre- and post-measurements for sensing and pacing thresholdsand impedances to determine the integrity and stability of the system.• For electrocautery, use a bipolar electrocautery system where possible and useshort, intermittent, and irregular bursts at the lowest feasible energy levels.• RF ablation equipment may cause telemetry interference between the pulsegenerator and PRM. If device programming changes are necessary during an RFablation procedure, turn off the RF ablation equipment before interrogation.When the procedure is finished, cancel the Electrocautery Protection Mode in order toreactivate the previously programmed therapy modes.32
Ionizing RadiationCAUTION: It is not possible to specify a safe radiation dosage or guarantee properpulse generator function following exposure to ionizing radiation. Multiple factorscollectively determine the impact of radiation therapy on an implanted pulse generator,including proximity of the pulse generator to the radiation beam, type and energylevel of the radiation beam, dose rate, total dose delivered over the life of the pulsegenerator, and shielding of the pulse generator. The impact of ionizing radiationwill also vary from one pulse generator to another and may range from no changesin function to a loss of pacing.Sources of ionizing radiation vary significantly in their potential impact on an implantedpulse generator. Several therapeutic radiation sources are capable of interfering withor damaging an implanted pulse generator, including those used for the treatmentof cancer, such as radioactive cobalt, linear accelerators, radioactive seeds, andbetatrons.Prior to a course of therapeutic radiation treatment, the patient’s radiation oncologistand cardiologist or electrophysiologist should consider all patient management options,including increased follow-up and device replacement. Other considerations include:• Maximizing shielding of the pulse generator within the treatment field• Determining the appropriate level of patient monitoring during treatment33
Evaluate pulse generator operation during and following the course of radiationtreatment to exercise as much device functionality as possible ("Post-Therapy PulseGenerator Follow Up" on page 27). The extent, timing, and frequency of this evaluationrelative to the radiation therapy regimen are dependent upon current patient health,and therefore should be determined by the attending cardiologist or electrophysiologist.Many pulse generator diagnostics are performed automatically once per hour, so pulsegenerator evaluation should not be concluded until pulse generator diagnostics havebeen updated and reviewed (at least one hour after radiation exposure). The effectsof radiation exposure on the implanted pulse generator may remain undetected untilsome time following exposure. For this reason, continue to monitor pulse generatorfunction closely and use caution when programming a feature in the weeks or monthsfollowing radiation therapy.Elevated PressuresThe International Standards Organization (ISO) has not approved a standardizedpressure test for implantable pulse generators that experience hyperbaric oxygentherapy (HBOT) or SCUBA diving. However, Boston Scientific developed a testprotocol to evaluate device performance upon exposure to elevated atmosphericpressures. The following summary of pressure testing should not be viewed as and isnot an endorsement of HBOT or SCUBA diving.34
CAUTION: Elevated pressures due to HBOT or SCUBA diving may damage thepulse generator. During laboratory testing, all pulse generators in the test samplefunctioned as designed when exposed to more than 1000 cycles at a pressure up to 5.0ATA. Laboratory testing did not characterize the impact of elevated pressure on pulsegenerator performance or physiological response while implanted in a human body.Pressure for each test cycle began at ambient/room pressure, increased to a highpressure level, and then returned to ambient pressure. Although dwell time (the amountof time under elevated pressure) may have an impact on human physiology, testingindicated it did not impact pulse generator performance. Pressure value equivalenciesare provided below (Table 1 on page 35).Table 1. Pressure Value EquivalenciesPressure value equivalenciesAtmospheres Absolute 5.0 ATASea water deptha40 m (130 ft)Pressure, absolute 72.8 psiaPressure, gaugeb58.8 psig35
Table 1. Pressure Value Equivalencies (continued)Pressure value equivalenciesBar 5.0kPa Absolute 500a. All pressures were derived assuming sea water density of 1030 kg/m3.b. Pressure as read on a gauge or dial (psia = psig + 14.7 psi).Prior to SCUBA diving or starting an HBOT program, the patient’s attendingcardiologist or electrophysiologist should be consulted to fully understand the potentialconsequences relative to the patient’s specific health condition. A Dive MedicineSpecialist may also be consulted prior to SCUBA diving.More frequent device follow-up may be warranted in conjunction with HBOT orSCUBA diving. Evaluate pulse generator operation following high pressure exposure("Post-Therapy Pulse Generator Follow Up" on page 27). The extent, timing, andfrequency of this evaluation relative to the high pressure exposure are dependentupon current patient health, and should be determined by the attending cardiologist orelectrophysiologist.If you have additional questions, or would like more detail regarding the test protocolor test results specific to HBOT or SCUBA diving, contact Boston Scientific using theinformationonthebackcover.36
POTENTIAL ADVERSE EVENTSBased on the literature and on pulse generator implant experience, the followingalphabetical list includes the possible adverse events associated with implantation ofa pulse generator and/or lead system:•Airembolism• Allergic reaction• Bleeding• Cardiac tamponade• Chronic nerve damage• Component failure• Conductor coil fracture• Death• Elevated thresholds•Erosion• Excessive fibrotic tissue growth• Extracardiac stimulation (muscle/nerve stimulation)• Foreign body rejection phenomena• Fluid accumulation• Formation of hematomas or seromas37
• Heart block• Inability to pace• Inappropriate pacing• Incisional pain• Incomplete lead connection with pulse generator• Infection including endocarditis• Lead dislodgment•Leadfracture• Lead insulation breakage or abrasion• Lead perforation• Lead tip deformation and/or breakage• Local tissue reaction• Myocardial infarction (MI)• Myocardial necrosis• Myocardial trauma (e.g., tissue damage, valve damage)• Myopotential sensing• Oversensing/undersensing• Pacemaker-mediated tachycardia (PMT) (Applies to dual-chamber devices only.)• Pericardial rub, effusion38
• Pneumothorax• Pulse generator migration• Shunting current during defibrillation with internal or external paddles• Tachyarrhythmias, which include acceleration of arrhythmias and early, recurrentatrial fibrillation• Thrombosis/thromboemboli• Valve damage• Venous occlusion• Venous trauma (e.g., perforation, dissection, erosion)• Worsening heart failurePatients may develop psychological intolerance to a pulse generator system and mayexperience the following:• Dependency• Depression• Fear of premature battery depletion• Fear of device malfunctionMECHANICAL SPECIFICATIONSMechanical and material specifications specific to each model are listed below.39
Table 2. Mechanical and Material SpecificationsK172 K173 K174Type SR DR DRConnector RA/RV: IS-1 RA:IS-1RV: IS-1RA:IS-1RV: IS-1DimensionsWxHxD(cm)4.45 x 4.57 x 0.75 4.45 x 4.70 x 0.75 4.45 x 5.56 x 0.75Volume (cm3)11.5 12.0 14.0Mass (g) 23.5 24.5 32.0Case ElectrodeSurface Area(cm2)29.78 29.78 35.98Case Material hermeticallysealed titaniumhermeticallysealed titaniumhermeticallysealed titaniumHeader Material implantation-gradepolymerimplantation-gradepolymerimplantation-gradepolymer40
Table 2. Mechanical and Material Specifications (continued)K172 K173 K174Power Supply Lithium-carbonmonofluoride-silver vanadiumoxide cellGreatbatch 2808Lithium-carbonmonofluoride-silver vanadiumoxide cellGreatbatch 2808Lithium-manganesedioxide cellBoston Scientific402125Usable BatteryCapacity (Ah)1.05 1.05 1.47Residual UsableBattery Capacityat Explant (Ah)0.06 0.08 0.08Models include ZIP telemetry operating with a transmit frequency of 916.5 MHz.ITEMS INCLUDED IN PACKAGEThe following items are included with the pulse generator:• One torque wrench• Product literature41
NOTE: Accessories (e.g., wrenches) are intended for one-time use only. They shouldnot be resterilized or reused.SYMBOLS ON PACKAGINGThe following symbols may be used on packaging and labeling (Table 3 on page 42):Table 3. Symbols on packagingSymbol DescriptionReference numberPackage contentsPulse generatorTorque wrench42
Table 3. Symbols on packaging (continued)Symbol DescriptionLiterature enclosedSerial numberUse byLot numberDate of manufactureNon-ionizing electromagnetic radiationSterilized using ethylene oxide43
Table 3. Symbols on packaging (continued)Symbol DescriptionDo not resterilizeDo not reuseDo not use if package is damagedConsult instructions for useTemperature limitation44
Table 3. Symbols on packaging (continued)Symbol DescriptionWand placement indicator for interrogationOpening instructionAuthorized Representative in the EuropeanCommunityManufacturerCHARACTERISTICS AS SHIPPEDRefer to the table for pulse generator settings at shipment (Table 4 on page 46).45
Table 4. Characteristics as shippedParameter SettingPacing Mode StoragePacing Therapy available DDDR (DR models) SSIR (SR models)Sensor Blend (Accel and MV)Pace/Sense Configuration RA: BI/BI (DR models)Pace/Sense Configuration RV: BI/BIMagnet Rate 100 ppmThe pulse generator is shipped in a power-saving Storage mode to extend its shelf life.In Storage mode, all features are inactive except:• Telemetry support, which allows interrogation and programming• Real-time clock• STAT PACE commandThe device leaves Storage mode when one of the following actions occurs; however,programming other parameters will not affect the Storage mode:46
• STAT PACE is commanded• The pulse generator automatically detects lead insertion (refer to "Implanting thePulse Generator" on page 59)• Device Mode is programmed to Exit StorageOnce you have programmed the pulse generator out of Storage mode, the devicecannot be reprogrammed to that mode.X-RAY IDENTIFIERThe pulse generator has an identifier that is visible on x-ray film or under fluoroscopy.This identifier provides noninvasive confirmation of the manufacturer and consists ofthe following:• The letters, BSC, to identify Boston Scientific as the manufacturer• The number, 011, to identify the Model 2869 PRM software application needed tocommunicate with the pulse generatorThe x-ray identifier is embedded in the header of the device at the approximate locationshown (Figure 1 on page 48).47
HeaderPulse Generator CaseX-Ray IdentifierFigure 1. X-ray identifierFor information on identifying the device via the PRM, refer to the PRM Operator’sManual.The pulse generator model number is stored in device memory and is shown on thePRM summary screen once the pulse generator is interrogated.FEDERAL COMMUNICATIONS COMMISSION (FCC)This device complies with Title 47, Part 15 of the FCC rules. Operation is subjectto the following two conditions:• This device may not cause harmful interference, and• This device must accept any interference received, including interference thatmay cause undesired operation.48
CAUTION: Changes or modifications not expressly approved by Boston Scientificcould void the user’s authority to operate the equipment.PULSE GENERATOR LONGEVITYBased on simulated studies, it is anticipated that these pulse generators have averagelongevity to explant as shown below.The longevity expectations, which account for the energy used during manufacture andstorage, apply at the conditions shown in the table along with the following:• Assumes 60 ppm LRL, ventricular and atrial settings of 0.4 ms pacing pulse width;sensors On.• These calculations also assume EGM Onset is set to On.Table 5. INGENIO Longevity Projections (Years)Amplitude andPacingModelsaK172 SR K173 DR K174 DR ELA and V Amplitudes 3.5 V100% Paced49
Table 5. INGENIO Longevity Projections (Years) (continued)Amplitude andPacingModelsa500 Ω7.3 5.5 8.0750 Ω7.9 6.3 9.01000 Ω8.4 6.8 9.650% Paced500 Ω8.5 7.0 9.9750 Ω9.0 7.5 10.71000 Ω9.2 7.8 11.2A and V Amplitudes 2.5 V100% Paced500 Ω8.5 6.9 9.8750 Ω8.9 7.5 10.71000 Ω9.2 7.9 11.250
Table 5. INGENIO Longevity Projections (Years) (continued)Amplitude andPacingModelsa50% Paced500 Ω9.3 7.9 11.3750 Ω9.5 8.4 11.81000 Ω9.6 8.6 12.1a. Assumes ZIP telemetry use for 1 hour at implant and for 20 minutes during each quarterlyfollow-up.Table 6. INGENIO Longevity Projections (Years) with Right VentricularAutomatic CaptureAmplitude andPacingModelsaK172 SR K173 DR K174 DR ELAutomatic Capture On (A = 3.5 Vb, V = 1.0 V [assuming a threshold of 0.5])100% Paced51
Table 6. INGENIO Longevity Projections (Years) with Right VentricularAutomatic Capture (continued)Amplitude andPacingModelsa500 Ω9.7 6.8 9.6750 Ω9.8 7.3 10.51000 Ω9.8 7.8 11.050% Paced500 Ω9.9 7.9 11.2750 Ω9.9 8.3 11.61000 Ω9.9 8.5 11.9Automatic Capture On (A = 2.5 Vb, V = 1.0 V [assuming a threshold of 0.5])100% Paced500 Ω9.7 7.8 11.0750 Ω9.8 8.2 11.552
Table 6. INGENIO Longevity Projections (Years) with Right VentricularAutomatic Capture (continued)Amplitude andPacingModelsa1000 Ω9.8 8.4 11.850% Paced500 Ω9.9 8.5 12.0750 Ω9.9 8.8 12.31000 Ω9.9 8.9 12.4a. Assumes ZIP telemetry use for 1 hour at implant and for 20 minutes during each quarterlyfollow-up.b. This value is not applicable in single chamber devices programmed to VVI(R).Longevities at “worst case” settings of 5.0 V, 500 Ω, 1.0 ms are: 3.2 years for K172;1.7 years for K173; 2.7 years for K174 at 70 ppm, and 2.4 years for K172; 1.1 yearsfor K173; 1.9 years for K174 at 100 ppm.Longevities at an LRL of 70 ppm, 500 Ω, 0.5 ms, 100% paced, sensors On, and pacingmode most comprehensive are: K172 at 2.5 V = 7.9 years, at 5.0 V = 4.7 years; K173 at2.5 V = 6.3 years, at 5.0 V = 2.9 years; K174 at 2.5 V = 8.9 years, at 5.0 V = 4.3 years.53
NOTE: The energy consumption in the longevity table is based upon theoreticalelectrical principles and verified via bench testing only.The pulse generator longevity may increase with a decrease in any of the following:•Pacingrate• Pacing pulse amplitude(s)• Pacing pulse width(s)• Percentage of paced to sensed eventsLongevity is also reduced in the following circumstances:• With a decrease in pacing impedance• When Patient Triggered Monitor is programmed to On for 60 days, longevity isreduced by approximately 5 days• One hour of additional ZIP wandless telemetry reduces longevity by approximately9 days.Device longevity may also be affected by:• Tolerances of electronic components• Variations in programmed parameters• Variations in usage as a result of patient condition54
Refer to the PRM Summary and Battery Detail Summary screens for an estimate ofpulse generator longevity specific to the implanted device.WARRANTY INFORMATIONA limited warranty certificate for the pulse generator is packaged with the device. Foradditional copies, contact Boston Scientific using the information on the back cover.PRODUCT RELIABILITYIt is Boston Scientific’s intent to provide implantable devices of high quality andreliability. However, these devices may exhibit malfunctions that may result in lost orcompromised ability to deliver therapy. These malfunctions may include the following:• Premature battery depletion• Sensing or pacing issues• Error codes• Loss of telemetryRefer to Boston Scientific’s CRM Product Performance Report onwww.bostonscientific.com for more information about device performance, includingthe types and rates of malfunctions that these devices have experienced historically.While historical data may not be predictive of future device performance, such datacan provide important context for understanding the overall reliability of these types ofproducts.55
Sometimes device malfunctions result in the issuance of product advisories. BostonScientific determines the need to issue product advisories based on the estimatedmalfunction rate and the clinical implication of the malfunction. When Boston Scientificcommunicates product advisory information, the decision whether to replace a deviceshould take into account the risks of the malfunction, the risks of the replacementprocedure, and the performance to date of the replacement device.PATIENT COUNSELING INFORMATIONThe following topics should be discussed with the patient prior to discharge.• External defibrillation—the patient should contact their physician to have theirpulse generator system evaluated if they receive external defibrillation• Signs and symptoms of infection• Symptoms that should be reported (e.g., sustained high-rate pacing requiringreprogramming)• Protected environments—the patient should seek medical guidance beforeentering areas protected by a warning notice that prevents entry by patients whohave a pulse generator• Avoiding potential sources of EMI in home, work, and medical environments• Reliability of their pulse generator ("Product Reliability" on page 55)56
• Activity restrictions (if applicable)• Minimum heart rate (lower rate limit of the pulse generator)• Frequency of follow up• Travel or relocation—Follow-up arrangements should be made in advance if thepatient is leaving the country of implant• Patient ID card—the patient should be advised to carry their patient ID card at alltimes (a temporary patient ID card is provided with the device, and a permanentID card will be sent to the patient 4 to 6 weeks after the implant form is receivedby Boston Scientific)Patient HandbookThe Patient Handbook is provided for each device.It is recommended that you discuss the information in the Patient Handbook withconcerned individuals both before and after implantation so they are fully familiar withpulse generator operation.For additional copies, contact Boston Scientific using the information on the back cover.57
LEAD CONNECTIONSLead connections are illustrated below.CAUTION: Prior to implantation, confirm the lead-to-pulse generator compatibility.Using incompatible leads and pulse generators can damage the connector and/orresult in potential adverse consequences, such as undersensing of cardiac activityor failure to deliver necessary therapy.CAUTION: If the Lead Configuration is programmed to Bipolar when a unipolar leadis implanted, pacing will not occur.IS-1UNI/BI[1] RA/RV [2] Suture HoleFigure 2. Lead connections and setscrew locations, RA/RV: IS158
RARVIS-1UNI/BIIS-1UNI/BI[1] RA [2] RV [3] Suture HoleFigure 3. Lead connections and setscrew locations, RA: IS-1, RV: IS-1NOTE: The pulse generator case is used as a pace electrode when the pulsegenerator has been programmed to a unipolar lead setting.IMPLANTING THE PULSE GENERATORImplant the pulse generator by performing the following steps in the sequence provided.Some patients may require pacing therapies immediately upon connecting the leadsto the pulse generator. If modifications to the nominal settings are needed, considerprogramming the pulse generator before or in parallel with implanting the lead systemand forming the implantation pocket.59
Step A: Check EquipmentIt is recommended that instrumentation for cardiac monitoring, defibrillation, and leadsignal measurement should be available during the implant procedure. This includesthe PRM system with its related accessories and the software application. Beforebeginning the implantation procedure, become completely familiar with the operation ofall the equipment and the information in the respective operator’s and user’s manuals.Verify the operational status of all equipment that may be used during the procedure. Incase of accidental damage or contamination, the following should be available:• Sterile duplicates of all implantable items• Sterile wand•SterilePSAcables• Torque and non-torque wrenches• External defibrillation equipmentStep B: Interrogate and Check the Pulse GeneratorTo maintain sterility, test the pulse generator as described below before opening thesterile blister tray. The pulse generator should be at room temperature to ensureaccurately measured parameters.60
1. Interrogate the pulse generator using the PRM. Verify that the pulse generator’sdevice mode is programmed to Storage. If otherwise, contact Boston Scientificusing the information on the back cover.2. Review the pulse generator’s current battery status. Counters should be at zero.If the pulse generator battery status is not at full capacity, do not implant the pulsegenerator. Contact Boston Scientific using the information on the back cover.3. If a unipolar pacing configuration is required at implant, program the leadconfiguration to unipolar before implant.Step C: Implant the Lead SystemThe pulse generator requires a lead system for pacing and sensing.Selection of lead configuration and specific surgical procedures is a matter ofprofessional judgment. The following leads are available for use with the pulsegenerator depending on the device model.• Unipolar or bipolar atrial lead• Unipolar or bipolar right ventricular lead.NOTE: Single-chamber devices can be used with either an atrial or a ventricular lead.NOTE: Using bipolar pacing leads will reduce the chance of myopotential sensing.61
CAUTION: The absence of a lead or plug in a lead port may affect deviceperformance. If a lead is not used, be sure to properly insert a plug in the unused port,and then tighten the setscrew onto the plug.CAUTION: If a dual-chamber device is programmed to AAI(R), ensure that afunctional RV lead is present. In the absence of a functional RV lead, programmingto AAI(R) may result in undersensing or oversensing.CAUTION: Do not suture directly over the lead body, as this may cause structuraldamage. Use the lead stabilizer to secure the lead proximal to the venous entry site toprevent lead movement.Implant the leads via the surgical approach chosen.When replacing a previously implanted pulse generator, it may be necessary to use anadapter to enable the new pulse generator to be connected to the existing leads. Whenusing an adapter, follow the connection procedure described in the applicable adapterproduct data sheet. Always connect the adapter to the lead and repeat threshold andsensing measurements before connecting the adapter to the pulse generator.Step D: Take Baseline MeasurementsOnce the leads are implanted, take baseline measurements. Evaluate the leadsignals. If performing a pulse generator replacement procedure, existing leads shouldbe reevaluated, (e.g., signal amplitudes, pacing thresholds, and impedance). The62
use of radiography may help ensure lead position and integrity. If testing results areunsatisfactory, lead system repositioning or replacement may be required.• Connect the pace/sense lead(s) to a pacing system analyzer (PSA).• Pace/sense lead measurements, measured approximately 10 minutes afterplacement, are listed below. Note that the pulse generator measurements maynot exactly correlate to the PSA measurements due to signal filtering.Table 7. Lead measurementsPace/ sense lead (acute) Pace/ sense lead(chronic)R-wave amplitudeab >5mV >5mVP-wave amplitudeab > 1.5 mV > 1.5 mVR-wave durationbcd < 100 ms < 100 msPacing threshold (rightventricle)< 1.5 V endocardial< 2.0 V epicardial< 3.0 V endocardial<3.5VepicardialPacing threshold (atrium) < 1.5 V endocardial < 3.0 V endocardial63
Table 7. Lead measurements (continued)Pace/ sense lead (acute) Pace/ sense lead(chronic)Lead impedance (at 5.0V and 0.5 ms atrium andright ventricle)200–2000 Ω200–2000 Ωa. Amplitudes less than 2 mV cause inaccurate rate counting in the chronic state, and result ininability to sense a tachyarrhythmia or the misinterpretation of a normal rhythm as abnormal.b. Lower R-wave amplitudes and longer duration may be associated with placement in ischemicor scarred tissues. Since signal quality may deteriorate chronically, efforts should be made tomeet the above criteria by repositioning the leads to obtain signals with the largest possibleamplitude and shortest duration.c. Durations longer than 135 ms (the pulse generator’s refractory period) may result in inaccuratecardiac rate determination, inability to sense a tachyarrhythmia, or in the misinterpretationof a normal rhythm as abnormal.d. This measurement is not inclusive of current of injury.Step E: Form the Implantation PocketUsing standard operating procedures to prepare an implantation pocket, choose theposition of the pocket based on the implanted lead configuration and the patient’sbody habitus. Giving consideration to patient anatomy and pulse generator size andmotion, gently coil any excess lead and place adjacent to the pulse generator. It is64
important to place the lead into the pocket in a manner that minimizes lead tension,twisting, sharp angles, and/or pressure. Pulse generators are typically implantedsubcutaneously in order to minimize tissue trauma and facilitate explant. However,deeper implantation (e.g., subpectoral) may help avoid erosion or extrusion in somepatients. Verify magnet function and wanded telemetry to ensure the pulse generator iswithin acceptable range.If an abdominal implant is suitable, it is recommended that implantation occur on theleft abdominal side.If it is necessary to tunnel the lead, consider the following:• If a Guidant tunneler is not used, cap the lead terminal pins. A Penrose drain,large chest tube, or tunneling tool may be used to tunnel the leads.• Gently tunnel the leads subcutaneously to the implantation pocket, if necessary.• Reevaluate all lead signals to determine if any of the leads have been damagedduring the tunneling procedure.If the leads are not connected to a pulse generator at the time of lead implantation,they must be capped before closing the incision.65
Step F: Connect the Leads to the Pulse GeneratorTo connect leads to the pulse generator, use only the tools provided in the pulsegenerator sterile tray or accessory kit. Failure to use the supplied torque wrench mayresult in damage to the setscrews, seal plugs, or connector threads. Do not implantthe pulse generator if the seal plugs appear to be damaged. Retain the tools until alltesting procedures are complete and the pulse generator is implanted.Automatic Lead DetectionUntil a right ventricular lead is detected (or any appropriate lead in a single chamberdevice), the lead impedance is measured in both unipolar and bipolar configurations.Upon insertion of the lead into the header the impedance measurement circuit willdetect an impedance which indicates that the device is implanted (automatic leaddetection). If the impedance is in range (200 – 2000 Ω, inclusive) the pulse generatorwill automatically switch to the nominal parameters and start sensing and deliveringtherapy. The pulse generator can also be programmed out of the Storage mode prior toimplant using the PRM.NOTE: If the lead being used for automatic lead detection is unipolar, an in-rangeimpedance will not be obtained until the pulse generator is in stable contact with thesubcutaneous tissue of the pocket.66
NOTE: Arrhythmia Logbook and stored EGM data will not be stored for the first twohours after the lead is detected except for PaceSafe and patient triggered episodes.If the device is programmed out of Storage, asynchronous pacing spikes could beobserved on intracardiac EGMs before bipolar RV lead insertion or before placing thepulse generator into the subcutaneous pocket if a unipolar RV lead is present. Thesesubthreshold spikes will not occur once a bipolar RV lead is detected in the header orwhen contact between the pacemaker case and subcutaneous tissue completes thenormal pacing circuit for a unipolar RV lead. If the device exits Storage as the result ofautomatic lead detection, the pulse generator may take up to 2 seconds plus one LRLinterval before pacing begins as a result of lead detection.Leads should be connected to the pulse generator in the following sequence (for pulsegenerator header and setscrew location illustrations, refer to "Lead Connections" onpage 58):NOTE: For single-chamber devices, use an RA or RV lead as appropriate.a. Right ventricle. Connect the RV lead first because it is required to establishRV-based timing cycles that yield appropriate sensing and pacing in all chambers,regardless of the programmed configuration.NOTE: Tightening the RV setscrew is not required for automatic lead detectionto occur but should be done to ensure full electrical contact.67
• In models with an IS-1 RV lead port, insert and secure the terminal pin ofan IS-1 RV pace/sense lead.b. Right atrium.• In models with an IS-1 RA lead port, insert and secure the terminal pin of anIS-1 atrial pace/sense lead.Connect each lead to the pulse generator by following these steps (for additionalinformation about the torque wrench, refer to "Bidirectional Torque Wrench" on page74):a. Check for the presence of any blood or other body fluids in the lead ports onthe pulse generator header. If fluid inadvertently enters the ports, clean themthoroughly with sterile water.b. If applicable, remove and discard the tip protection before using the torque wrench.c. Gently insert the torque wrench blade into the setscrew by passing it through thepreslit, center depression of the seal plug at a 90° angle (Figure 4 on page 69).This will open up the seal plug, relieving any potential pressure build-up from thelead port by providing a pathway to release trapped fluid or air.NOTE: Failure to properly insert the torque wrench in the preslit depression ofthe seal plug may result in damage to the plug and its sealing properties.68
CAUTION: Do not insert a lead into the pulse generator connector without takingthe following precautions to ensure proper lead insertion:• Insert the torque wrench into the preslit depression of the seal plug beforeinserting the lead into the port, to release any trapped fluid or air.• Visually verify that the setscrew is sufficiently retracted to allow insertion.Use the torque wrench to loosen the setscrew if necessary.• Fully insert each lead into its lead port and then tighten the setscrew ontothe terminal pin.Figure 4. Inserting the torque wrench69
d. With the torque wrench in place, fully insert the lead terminal into the lead port.The lead terminal pin should be clearly visible beyond the connector block whenviewed through the side of the pulse generator header. Place pressure on the leadto maintain its position and ensure that it remains fully inserted in the lead port.CAUTION: Insert the lead terminal straight into the lead port. Do not bend thelead near the lead-header interface. Improper insertion can cause insulationor connector damage.NOTE: If necessary, lubricate the lead connectors sparingly with sterile water tomake insertion easier.NOTE: For IS-1 leads, be certain that the terminal pin visibly extends beyondthe connector block at least 1 mm.e. Apply gentle downward pressure on the torque wrench until the blade is fullyengaged within the setscrew cavity, taking care to avoid damage to the sealplug. Tighten the setscrew by slowly turning the torque wrench clockwise, until itratchets once. The torque wrench is preset to apply the proper amount of force tothe captive setscrew; additional rotation and force is unnecessary.f. Remove the torque wrench.g. Apply gentle traction to the lead to ensure a secure connection.70
h. If the lead terminal is not secure, attempt to reseat the setscrew. Reinsert thetorque wrench as described above, and loosen the setscrew by slowly turning thewrench counterclockwise, until the lead is loose. Then repeat the sequence above.i. If a lead port is not used, insert a plug into the unused port and tighten thesetscrew.CAUTION: The absence of a lead or plug in a lead port may affect deviceperformance. If a lead is not used, be sure to properly insert a plug in the unusedport, and then tighten the setscrew onto the plug.Step G: Evaluate Lead Signals1. Evaluate the pace/sense lead signals by viewing the real-time EGMs and markers.Lead measurements should reflect those above (Table 7 on page 63)Depending on the patient’s intrinsic rhythm, it may be necessary to temporarilyadjust pacing parameters to allow assessment of pacing and sensing. If properpacing and/or sensing are not demonstrated, disconnect the lead from the pulsegenerator and visually inspect the connector and leads. If necessary, retest thelead.CAUTION: Take care to ensure that artifacts from the ventricles are not present onthe atrial channel, or atrial oversensing may result. If ventricular artifacts are present inthe atrial channel, the atrial lead may need to be repositioned to minimize its interaction.71
2. Evaluate all lead impedances.Step H: Program the Pulse Generator1. Check the programmer clock and set and synchronize the pulse generator asnecessary so that the proper time appears on printed reports and PRM stripchart recordings.2. Program the pulse generator appropriately if a lead port(s) is not used.Step I: Implant the Pulse Generator1. Ensure that the pulse generator has good contact with surrounding tissue of theimplantation pocket, and then suture it in place to minimize device migration (forsuture hole location illustrations, refer to "Lead Connections" on page 58). Gentlycoil excess lead and place adjacent to the pulse generator. Flush the pocket withsaline solution, if necessary, to avoid a dry pocket.WARNING: Do not kink, twist, or braid the lead with other leads as doing socould cause lead insulation abrasion damage or conductor damage.2. Close the implantation pocket. Consideration should be given to place the leadsin a manner to prevent contact with suture materials. It is recommended thatabsorbable sutures be used for closure of tissue layers.72
3. If Electrocautery mode was used during the implant procedure, cancel it whendone.4. Confirm final programmed parameters.CAUTION: Following any Sensitivity parameter adjustment or any modificationof the sensing lead, always verify appropriate sensing. Programming Sensitivityto the highest value (lowest sensitivity) may result in undersensing of cardiacactivity. Likewise, programming to the lowest value (highest sensitivity) may resultin oversensing of non-cardiac signals.5. Use the PRM to print out parameter reports and save all patient data.Step J: Complete and Return the Implantation FormWithin ten days of implantation, complete the Warranty Validation and Lead Registrationform and return the original to Boston Scientific along with a copy of the patient datasaved from the PRM. This information enables Boston Scientific to register eachimplanted pulse generator and set of leads, initiate the warranty period, and provideclinical data on the performance of the implanted system. Keep a copy of the WarrantyValidation and Lead Registration form and programmer printouts, and the originalpatient data for the patient’s file.73
Complete the temporary patient identification card and give it to the patient. Afterreceiving the validation form, Boston Scientific sends the patient a permanentidentification card.NOTE: A registration form is packaged with each pulse generator lead. If completingthe pulse generator Warranty Validation and Lead Registration form for the pulsegenerator, completing separate validation forms for each lead is not necessary.BIDIRECTIONAL TORQUE WRENCHA torque wrench (model 6628) is included in the sterile tray with the pulse generator,and is designed for tightening and loosening #2-56 setscrews, captured setscrews, andsetscrews on this and other Boston Scientific pulse generators and lead accessoriesthat have setscrews that spin freely when fully retracted (these setscrews typicallyhave white seal plugs).This torque wrench is bidirectional, and is preset to apply adequate torque to thesetscrew and will ratchet when the setscrew is secure. The ratchet release mechanismprevents overtightening that could result in device damage. To facilitate the looseningof tight extended setscrews, this wrench applies more torque in the counterclockwisedirection than in the clockwise direction.NOTE: As an additional safeguard, the tip of the torque wrench is designed to breakoff if used to overtighten beyond preset torque levels. If this occurs, the broken tip mustbe extracted from the setscrew using forceps.74
This torque wrench may also be used for loosening setscrews on other BostonScientific pulse generators and lead accessories that have setscrews that tightenagainst a stop when fully retracted (these setscrews typically have clear seal plugs).However, when retracting these setscrews, stop turning the torque wrench when thesetscrew has come in contact with the stop. The additional counterclockwise torque ofthis wrench may cause these setscrews to become stuck if tightened against the stop.Loosening Stuck SetscrewsFollow these steps to loosen stuck setscrews:1. From a perpendicular position, tilt the torque wrench to the side 20º to 30º fromthe vertical center axis of the setscrew (Figure 5 on page 76).2. Rotate the wrench clockwise (for retracted setscrew) or counterclockwise (forextended setscrew) around the axis three times, such that the handle of thewrench orbits the centerline of the screw (Figure 5 on page 76). The torquewrench handle should not turn or twist during this rotation.3. As needed, you may attempt this up to four times with slightly more angle eachtime. If you cannot fully loosen the setscrew, use the #2 torque wrench fromWrench Kit Model 6501.4. Once the setscrew has been freed, it may be extended or retracted as appropriate.5. Discard the torque wrench upon completion of this procedure.75
20°–30°[1] Clockwise rotation to free setscrews stuck in the retracted position [2]Counterclockwise rotation to free setscrews stuck in the extended positionFigure 5. Rotating the torque wrench to loosen a stuck setscrewFOLLOW UP TESTINGIt is recommended that device functions be evaluated with periodic follow-up testing bytrained personnel. Follow up guidance below will enable thorough review of deviceperformance and associated patient health status throughout the life of the device.76
Predischarge Follow UpThe following procedures are typically performed during the predischarge follow uptest using PRM telemetry:1. Interrogate the pulse generator and review the Summary screen.2. Verify pacing thresholds, lead impedance, and amplitude of intrinsic signals.3. Review counters and histograms.4. When all testing is complete, perform a final interrogation and save all the patientdata.5. Print the Quick Notes and Patient Data reports to retain in your files for futurereference.6. Clear the counters and histograms so that the most recent data will be displayedat the next follow up session. Counters and histograms can be cleared bypressing Reset on the Histogram screen, Tachy Counters screen, or BradyCounters screen.Routine Follow UpDuring early and middle life of the device, monitor performance by routine follow upone month after the predischarge check and at least annually thereafter. Office visits77
may be supplemented by remote monitoring where available. As always, the physicianshould evaluate the patient’s current health status, device status and parameter values,and local medical guidelines to determine the most appropriate follow up schedule.When the device reaches One Year Remaining status and/or a magnet rate of 90 ppmis observed, follow up at least every three months to facilitate timely detection ofreplacement indicators.NOTE: Because the duration of the device replacement timer is three months (startingwhen Explant status is reached), three month follow up frequency is particularlyimportant after the One Year Remaining status is reached.Consider performing the following procedures during a routine follow-up test:1. Interrogate the pulse generator and review the Summary screen.2. Verify pacing thresholds, lead impedance, and amplitude of intrinsic signals.3. Print the Quick Notes and Patient Data reports to retain in your files for futurereference.4. Review the Arrhythmia Logbook screen and for episodes of interest, print episodedetails and stored electrogram information.5. Clear the counters and histograms so that the most recent episode data will bedisplayed at the next follow-up session.78
6. Verify that important programmed parameter values (e.g., lower rate limit, AVDelay, rate adaptive pacing, output amplitude, pulse width, sensitivity) are optimalfor current patient status.NOTE: Echo-Doppler studies may be used to non-invasively evaluate AV Delay andother programming options post-implant.EXPLANTATIONNOTE: Return all explanted pulse generators and leads to Boston Scientific.Examination of explanted pulse generators and leads can provide information forcontinued improvement in system reliability and warranty considerations.WARNING: Do not reuse, reprocess, or resterilize. Reuse, reprocessing, orresterilization may compromise the structural integrity of the device and/or lead todevice failure which, in turn, may result in patient injury, illness, or death. Reuse,reprocessing, or resterilization may also create a risk of contamination of the deviceand/or cause patient infection or cross-infection, including, but not limited to, thetransmission of infectious disease(s) from one patient to another. Contamination of thedevice may lead to injury, illness, or death of the patient.Complete and send an Observation/Complication/Out-of-Service Reporting form toBoston Scientific when any of the following occur:• When a product is removed from service.79
• In the event of patient death (regardless of cause), along with an autopsy report,if performed.• For other observation or complications reasons.NOTE: Disposal of explanted pulse generators and/or leads is subject to applicablelaws and regulations. For a Returned Product Kit, contact Boston Scientific using theinformationonthebackcover.NOTE: Discoloration of the pulse generator may have occurred due to a normalprocess of anodization, and has no effect on the pulse generator function.CAUTION: Be sure that the pulse generator is removed before cremation. Cremationand incineration temperatures might cause the pulse generator to explode.CAUTION: Before explanting, cleaning, or shipping the device, complete the followingactions to prevent overwriting of important therapy history data:• Program the pulse generator Brady Mode to Off• Program Ventricular Tachy EGM Storage to OffClean and disinfect the device using standard biohazard handling techniques.Consider the following items when explanting and returning the pulse generator and/orlead:80
• Interrogate the pulse generator and print a Combined Follow-up report.• Deactivate the pulse generator before explantation.• Disconnect the leads from the pulse generator.• If leads are explanted, attempt to remove them intact, and return them regardlessof condition. Do not remove leads with hemostats or any other clamping toolthat may damage the leads. Resort to tools only if manual manipulation cannotfree the lead.• Wash, but do not submerge, the pulse generator and leads to remove body fluidsand debris using a disinfectant solution. Do not allow fluids to enter the pulsegenerator’s lead ports.• UseaBostonScientific Returned Product Kit to properly package the pulsegenerator and send it to Boston Scientific.81
82
For additional technical reference guides, go towww.bostonscientific.com/ifu.Boston Scientific4100 Hamline Avenue NorthSt. Paul, MN 55112–5798 USAwww.bostonscientific.com1.800.CARDIAC (227.3422)+1.651.582.4000© 2011 Boston Scientificoritsaffiliates.All rights reserved.358566-004 EN US 6/11FCC ID: ESCCRMV17311 *358566-004*

Navigation menu