Boston Scientific CRMU22814 L300, L301, L321, L310, L311, L331, L200, L201, L221, L210, L211, L231, L100, L101, L121, L110, L111, L131, U225, U226, U228, U125, U128 User Manual

Boston Scientific Corporation L300, L301, L321, L310, L311, L331, L200, L201, L221, L210, L211, L231, L100, L101, L121, L110, L111, L131, U225, U226, U228, U125, U128

User Manual

PHYSICIAN’S TECHNICAL MANUALVALITUDE™, VALITUDE™X4,INTUA™,INVIVE™CARDIAC RESYNCHRONIZATION THERAPYPACEMAKERModel U125, U128, V272, V273, V172, V173CAUTION: 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 Information..................................................................................................................... 1Device Description.......................................................................................................................... 1Related Information ........................................................................................................................ 3Indications and Usage .................................................................................................................... 4Contraindications............................................................................................................................ 4Warnings ........................................................................................................................................ 5Precautions..................................................................................................................................... 7Supplemental Precautionary Information ..................................................................................... 20Post-Therapy Pulse Generator Follow Up .......................................................................... 20Minimizing Pacemaker/S-ICD Interaction ........................................................................... 21Transcutaneous Electrical Nerve Stimulation (TENS)......................................................... 23Electrocautery and Radio Frequency (RF) Ablation............................................................ 24Ionizing Radiation................................................................................................................ 26Elevated Pressures ............................................................................................................. 27Potential Adverse Events ............................................................................................................. 28Mechanical Specifications ............................................................................................................ 31Items Included in Package ........................................................................................................... 34Symbols on Packaging ................................................................................................................. 34Characteristics as Shipped........................................................................................................... 38X-Ray Identifier............................................................................................................................. 39Federal Communications Commission (FCC) .............................................................................. 41Pulse Generator Longevity........................................................................................................... 42Warranty Information .................................................................................................................... 46Product Reliability......................................................................................................................... 46Patient Counseling Information ....................................................................................................47Patient Handbook................................................................................................................ 48Lead Connections......................................................................................................................... 48
Implanting the Pulse Generator.................................................................................................... 52Step A: Check Equipment ................................................................................................ 52Step B: Interrogate and Check the Pulse Generator ........................................................ 52Step C: Implant the Lead System..................................................................................... 53Step D: Take Baseline Measurements ............................................................................. 54Step E: Form the Implantation Pocket.............................................................................. 57Step F: Connect the Leads to the Pulse Generator.......................................................... 58Step G: Evaluate Lead Signals......................................................................................... 62Step H: Program the Pulse Generator.............................................................................. 63Step I: Implant the Pulse Generator ................................................................................. 64Step J: Complete and Return the Implantation Form ....................................................... 65Bidirectional Torque Wrench......................................................................................................... 66Follow Up Testing ......................................................................................................................... 68Predischarge Follow Up ...................................................................................................... 68Routine Follow Up............................................................................................................... 68Explantation.................................................................................................................................. 69
ADDITIONAL INFORMATIONFor additional reference information, go to www.bostonscientific.com/ifu.DEVICE DESCRIPTIONThis manual contains information about the VALITUDE, INTUA, and INVIVE families of cardiacresynchronization therapy pacemakers (CRT-Ps) (specific models are listed in "Mechanical Specifications"on page 31).NOTE: Specific features discussed in this manual may not apply to all models. References to names ofnon-quadripolar devices also apply to the corresponding quadripolar devices. References to “ICD” include alltypes of ICDs (e.g., ICD, CRT-D, S-ICD).TherapiesThese pulse generators provide a variety of therapies, including:• Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricularcontractions through biventricular electrical stimulation• Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmiasLeadsThe pulse generator has independently programmable outputs and accepts one or more of the followingleads, depending on the model:•OneIS-11unipolar or bipolar atrial lead• One IS-1 unipolar or bipolar right ventricular lead• One LV-1 unipolar or bipolar left ventricular lead1. IS-1 refers to the international standard ISO 5841-3:2013.1
• One IS-1 unipolar or bipolar left ventricular lead• One compatible IS42quadripolar left ventricular lead3The pulse generator and the leads constitute the implantable portion of the pulse generator system.PRM SystemThese pulse generators can be used only with the ZOOM LATITUDE Programming System, which is theexternal portion of the pulse generator system and includes:• Model 3120 Programmer/Recorder/Monitor (PRM)• Model 3140 ZOOM Wireless Transmitter• Model 2869 ZOOMVIEW Software Application• Model 6577 Accessory Telemetry WandYou 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 data• Store a 12 second trace of the ECG/EGM display from any screen• Access an interactive Demonstration Mode or Patient Data Mode without the presence of a pulsegenerator• Print patient data including pulse generator therapy options and therapy history data2. IS4 refers to the international standard ISO 27186:2010.3. Compatibility with St. Jude Quartet IS4 lead has been demonstrated through chronic in-vivo animal GLP testing.2
• Save patient dataYou can program the pulse generator using two methods: automatically using Indications-Based Programming(IBP) or manually.RELATED INFORMATIONRefer to the lead’s instruction manual for implant information, general warnings and precautions, indications,contraindications, and technical specifications. Read this material carefully for implant procedure instructionsspecific to the chosen lead configurations.Refer to the PRM system Operator’s Manual or ZOOM Wireless Transmitter Reference Guide for specificinformation about the PRM or ZOOM Wireless Transmitter such as setup, maintenance, and handling.LATITUDE NXT is a remote monitoring system that provides pulse generator data for clinicians. These pulsegenerators are designed to be LATITUDE NXT enabled; availability varies by region.LATITUDE NXT is available for the following devices: VALITUDE, INTUA, INVIVE.• Physicians/Clinicians—LATITUDE NXT enables you to periodically monitor both patient and devicestatus remotely and automatically. The LATITUDE NXT system provides patient data that can be usedas part of the clinical evaluation of the patient.• Patients—A key component of the system is the LATITUDE Communicator, an easy-to-use, in-homemonitoring device. The Communicator automatically reads implanted device data from a compatibleBoston Scientific pulse generator at times scheduled by the physician. The Communicator sends thisdata to the LATITUDE NXT secure server through a standard analog telephone line or over a cellular datanetwork. The LATITUDE NXT server displays the patient data on the LATITUDE NXT Web site, which isreadily accessible over the Internet to authorized physicians and clinicians.Refer to the LATITUDE NXT Clinician Manual for more information.3
INTENDED AUDIENCEThis literature is intended for use by professionals trained or experienced in device implant and/or follow-upprocedures.INDICATIONS AND USAGEBoston Scientific cardiac resynchronization therapy pacemakers (CRT-Ps) are indicated for patients withmoderate to severe heart failure (NYHA Class III/IV) including left ventricular dysfunction (EF ≤35%) andQRS duration ≥120 ms and remain symptomatic despite stable optimal pharmacological therapy (OPT)for heart failure.Atrial tracking modes are also indicated for patients who may benefit from maintenance of AV synchrony.Adaptive-rate pacing is indicated for patients exhibiting chronotropic incompetence and who would benefitfromincreased pacing rates concurrent with increases in physical activity.CONTRAINDICATIONSThese Boston Scientific pulse generators have the following contraindications:• This device is contraindicated in patients who have a separate implanted cardioverter defibrillator (ICD)with transvenous leads.• Unipolar pacing or use of the Respiratory Sensor with a Subcutaneous Implantable CardioverterDefibrillator (S-ICD) is contraindicated because it may cause inappropriate therapy or inhibition ofappropriate S-ICD therapy.• Single-chamber atrial pacing is contraindicated in patients with impaired AV nodal conduction.• Atrial tracking modes are contraindicated in patients with chronic refractory atrial tachyarrhythmias (atrialfibrillation or flutter), which might trigger ventricular pacing.• Asynchronous pacing is contraindicated in the presence (or likelihood) of competition between pacedand intrinsic rhythms.4
WARNINGSGeneral• Labeling knowledge. Read this manual thoroughly before implantation to avoid damage to the pulsegenerator and/or lead. Such damage can result in patient injury or death.• For single patient use only. Do not reuse, reprocess, or resterilize. Reuse, reprocessing, orresterilization may compromise the structural integrity of the device and/or lead to device failure which, inturn, may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization may also createa risk of contamination of the device and/or cause patient infection or cross-infection, including, but notlimited to, the transmission of infectious disease(s) from one patient to another. Contamination of thedevice may lead to injury, illness, or death of the patient.• Backup defibrillation protection. Always have external defibrillation equipment available duringimplant and electrophysiologic testing. If not terminated in a timely fashion, an induced ventriculartachyarrhythmia can result in the patient’s death.• Separate pulse generator. Using multiple pulse generators could cause pulse generator interaction,resulting in patient injury or a lack of therapy delivery. Test each system individually and in combination tohelp prevent undesirable interactions ("Minimizing Pacemaker/S-ICD Interaction" on page 21).• Safety Core operation. In response to applicable nonrecoverable or repeat fault conditions, the pulsegenerator will switch irreversibly to Safety Core operation. Safety Core pacing is unipolar, which mayinteract with an ICD ("Minimizing Pacemaker/S-ICD Interaction" on page 21).Handling• Do not kink leads. Do not kink, twist, or braid the lead with other leads as doing so could cause leadinsulation abrasion damage or conductor damage.5
• Handling the lead without Connector Tool. For leads that require the use of a Connector Tool, usecaution handling the lead terminal when the Connector Tool is not present on the lead. Do not directlycontact the lead terminal with any surgical instruments or electrical connections such as PSA (alligator)clips, ECG connections, forceps, hemostats, and clamps. This could damage the lead terminal, possiblycompromising the sealing integrity and result in loss of therapy or inappropriate therapy, such as ashort within the header.• Handling the terminal while tunneling. Do not contact any other portion of the IS4–LLLL lead terminal,other than the terminal pin, even when the lead cap is in place.Programming and Device Operations• Atrial tracking modes. Do not use atrial tracking modes in patients with chronic refractory atrialtachyarrhythmias. Tracking of atrial arrhythmias could result in ventricular tachyarrhythmias.• Atrial-only modes. Do not use atrial-only modes in patients with heart failure because such modes donot provide CRT.• Lead Safety Switch. Lead Safety Switch should be programmed Off for patients with an ICD. Unipolarpacing due to Lead Safety Switch is contraindicated for patients with an ICD.• RAAT testing. Unipolar pacing due to RAAT is contraindicated and should be programmed off for patientswith an ICD. The RAAT feature performs automatic threshold testing in a unipolar pacing configuration.• Ventricular sensing. Left ventricular lead dislodgement to a position near the atria can result in atrialoversensing and left ventricular pacing inhibition.• Sensitivity settings and EMI. If programmed to a fixed atrial Sensitivity value of 0.15 mV, or a fixedsensitivity value of 2.0 mV or less in a unipolar lead configuration in any chamber, the pulse generatormay be more susceptible to electromagnetic interference. This increased susceptibility should be takeninto consideration when determining the follow-up schedule for patients requiring such a setting.6
Post-Implant• Protected environments. Advise patients to seek medical guidance before entering environments thatcould adversely affect the operation of the active implantable medical device, including areas protectedby a warning notice that prevents entry by patients who have a pulse generator.• Magnetic Resonance Imaging (MRI) exposure. Do not expose a patient to MRI scanning. Strongmagnetic fields may damage the pulse generator and/or lead system, possibly resulting in injury toor death of the patient.•Diathermy.Do not subject a patient with an implanted pulse generator and/or lead to diathermy sincediathermy may cause fibrillation, burning of the myocardium, and irreversible damage to the pulsegenerator because of induced currents.PRECAUTIONSClinical Considerations• STAT PACE. STAT PACE will initiate unipolar pacing. Unipolar pacing due to STAT PACE may causeinappropriate therapy or inhibition of appropriate S-ICD therapy.• Pacemaker-mediated tachycardia (PMT). Programming minimum PVARP less than retrograde V–Aconduction may increase the likelihood of a PMT.• Rate Adaptive Pacing in Heart Failure Patients. The clinical benefit of Rate Adaptive Pacing in heartfailure patients has not been studied. Rate Adaptive Pacing should be used with medical discretion if thepatient develops an indication such as chronotropic incompetence. Patients with heart failure may havehemodynamic compromise at rapid sensor-driven rates, and the physician may wish to program lessaggressive rate adaptive parameters in accordance with patient condition. Rate Adaptive Pacing may behelpful for heart failure patients with coexisting bradyarrhythmic conditions. It is not recommended forpatients who exhibit only heart failure-induced chronotropic incompetency.7
Sterilization and Storage• If package is damaged. The blister trays and contents are sterilized with ethylene oxide gas beforefinal packaging. When the pulse generator and/or lead is received, it is sterile provided the container isintact. If the packaging is wet, punctured, opened, or otherwise damaged, return the pulse generatorand/or lead to Boston Scientific.• If device is dropped. Do not implant a device which has been dropped while outside of its intact shelfpackage. Do not implant a device which has been dropped from a height of more than 24 inches (61 cm)while within its intact shelf package. Sterility, integrity and/or function cannot be guaranteed under theseconditions and the device should be returned to Boston Scientific for inspection.• Storage temperature and equilibration. Recommended storage temperatures are 0°C–50°C(32°F–122°F). Allow the device to reach a proper temperature before using telemetry communicationcapabilities, programming or implanting the device because temperature extremes may affect initialdevice function.•Devicestorage.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 BY date on the packagelabel because this date reflects a validated shelf life. For example, if the date is January 1, do notimplant on or after January 2.Implantation• Expected benefits. Determine whether the expected device benefits provided by programmable optionsoutweigh the possibility of more rapid battery depletion.• Evaluate patient for surgery. There may be additional factors regarding the patient’s overall healthand medical condition that, while not related to device function or purpose, could render the patient apoor candidate for implantation of this system. Cardiac health advocacy groups may have publishedguidelines that may be helpful in conducting this evaluation.8
• Lead compatibility. Prior to implantation, confirm the lead-to-pulse generator compatibility. Usingincompatible leads and pulse generators can damage the connector and/or result in potential adverseconsequences, such as undersensing of cardiac activity or failure to deliver necessary therapy.• Telemetry wand. Make sure a sterile telemetry wand is available should loss of ZIP telemetry occur.Verify that the wand can easily be connected to the programmer and is within reach of the pulse generator.• Line-powered equipment. Exercise extreme caution if testing leads using line-powered equipmentbecause leakage current exceeding 10 µA can induce ventricular fibrillation. Ensure that any line-poweredequipment is within specifications.• Replacement device. Implanting a replacement device in a subcutaneous pocket that previously houseda larger device may result in pocket air entrapment, migration, erosion, or insufficient grounding betweenthe device and tissue. Irrigating the pocket with sterile saline solution decreases the possibility ofpocket air entrapment and insufficient grounding. Suturing the device in place reduces the possibility ofmigration and erosion.• Do not bend the lead near the lead-header interface. Insert the lead terminal straight into the leadport. Do not bend the lead near the lead-header interface. Improper insertion can cause insulationor connector damage.• Absence of a lead. The absence of a lead or plug in a lead port may affect device performance. If alead is not used, be sure to properly insert a plug in the unused port, and then tighten the setscrewonto the plug.• Dual chamber device without a functional RV lead. If a dual-chamber device is programmed toAAI(R), ensure that a functional RV lead is present. In the absence of a functional RV lead, programmingto AAI(R) may result in undersensing or oversensing.9
• Electrode connections. Do not insert a lead into the pulse generator connector without taking thefollowing precautions to ensure proper lead insertion:• Insert the torque wrench into the preslit depression of the seal plug before inserting the lead into theport, to release any trapped fluid or air.• Visually verify that the setscrew is sufficiently retracted to allow insertion. Use the torque wrenchto loosen the setscrew if necessary.• Fully insert each lead into its lead port and then tighten the setscrew onto the terminal pin.• Do not suture directly over lead. Do not suture directly over the lead body, as this may cause structuraldamage. Use the suture sleeve to secure the lead proximal to the venous entry site to prevent leadmovement.• Diaphragmatic stimulation. Patients should be tested for diaphragmatic stimulation by pacing the LVlead through the pulse generator at 7.5 V and adjusting the lead configurations and lead position asnecessary. PSA testing at higher outputs (e.g., 10.0 V) may also be considered to better characterizestimulation margins. The probability of diaphragmatic stimulation increases when a pacing systemincludes an LV lead because of this lead’s proximity to the phrenic nerve.Device Programming• Device communication. Use only the designated PRM and software application to communicatewith this pulse generator.• STAT PACE settings. When a pulse generator is programmed to STAT PACE settings, it will continue topace at the high-energy STAT PACE values if it is not reprogrammed. The use of STAT PACE parameterswill likely decrease device longevity.10
• Biventricular pacing therapy. This device is intended to provide biventricular pacing therapy.Programming the device to provide RV-only pacing, or programming the RV pace amplitude below thepacing threshold (resulting in LV-only pacing), is not intended for the treatment of heart failure. Theclinical effects of LV-only or RV-only pacing for the treatment of heart failure have not been established.• Pacing and sensing margins. Consider lead maturation in your choice of Pacing Amplitude, pacingPulse Width, and Sensitivity settings.• An acute Pacing Threshold greater than 1.5 V or a chronic Pacing Threshold greater than 3 V canresult in loss of capture because thresholds may increase over time.• An R-Wave Amplitude less than 5 mV or a P-Wave Amplitude less than 2 mV can result inundersensing because the sensed amplitude may decrease after implantation.• Pacing Lead Impedance should be greater than the programmed Low Impedance Limit and lessthan 2000 Ω(or the programmed High Impedance Limit).• Lead impedance values and Lead Safety Switch. If properly functioning leads with stable measuredimpedance values near the programmed impedance limits are used, consider programming LeadSafety Switch Off or changing the impedance limits to avoid undesirable switching to a Unipolar LeadConfiguration.• Proper programming of the lead configuration. If the Lead Configuration is programmed to Bipolarwhen a unipolar lead is implanted, pacing will not occur.• Programming for supraventricular tachyarrhythmias (SVTs). Determine if the device andprogrammable options are appropriate for patients with SVTs because SVTs can initiate unwanteddevice therapy.• AV Delay. To ensure a high percentage of biventricular pacing, the programmed AV Delay settingmust be less than the patient’s intrinsic PR interval.• Adaptive-rate pacing. Rate Adaptive Pacing should be used with care in patients who are unable totolerate increased pacing rates.11
• Ventricular refractory periods (VRPs) in adaptive-rate pacing. Adaptive-rate pacing is not limited byrefractory periods. A long refractory period programmed in combination with a high MSR can result inasynchronous pacing during refractory periods since the combination can cause a very small sensingwindow or none at all. Use Dynamic AV Delay or Dynamic PVARP to optimize sensing windows. If youare programming a fixed AV Delay, consider the sensing outcomes.• MTR/MSR programming. The pulse generator’s MTR and MSR should be programmed to a rate lowerthan a concomitant S-ICD’s lowest tachycardia detection zone.• Atrial Tachy Response (ATR). ATR should be programmed to On if the patient has a history of atrialtachyarrhythmias. The delivery of CRT is compromised because AV synchrony is disrupted if the ATRmode switch occurs.• Threshold test. During a manual LV Threshold test, RV Backup Pacing is unavailable.• Left ventricular pacing only. The clinical effect of LV pacing alone for heart failure patients has notbeen studied.• Atrial oversensing. Take care to ensure that artifacts from the ventricles are not present on the atrialchannel, or atrial oversensing may result. If ventricular artifacts are present in the atrial channel, theatrial lead may need to be repositioned to minimize its interaction.• ATR entry count. Exercise care when programming the Entry Count to low values in conjunction witha short ATR Duration. This combination allows mode switching with very few fast atrial beats. Forexample, if the Entry Count was programmed to 2 and the ATR Duration to 0, ATR mode switching couldoccur on 2 fast atrial intervals. In these instances, a short series of premature atrial events could causethe device to mode switch.• ATR exit count. Exercise care when programming the Exit Count to low values. For example, if theExit Count was programmed to 2, a few cycles of atrial undersensing could cause termination of modeswitching.12
• 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 connected to the header, device programming should beconsistent with the number and type of leads actually in use.• Atrial sensing programmed to Off. When atrial sensing is programmed to Off in a DDI(R) or DDD(R)mode, any atrial pacing that occurs will be asynchronous. Additionally, features that require atrial sensingmay not function as expected.• High atrial rates. Sensing high atrial rates may impact device longevity. Therefore, the Atrial Senselead configuration will be seeded to Off when programming from an atrial sensing mode to a non-atrialsensing mode.• Cross-chamber artifacts. Sensitivity adjustments associated with Smart Blanking may not be sufficientto inhibit detection of cross-chamber artifacts if the cross-chamber artifacts are too large. Consider otherfactors that impact the size/amplitude of cross-chamber artifacts including lead-placement, pacing output,and programmed Sensitivity settings.• Sensor signal artifacts. If Respiratory Sensor signal artifacts are observed on EGMs, and the leadsare otherwise shown to be performing appropriately, consider programming the sensor to Off to preventoversensing.• Single pass VDD leads. When a single pass VDD lead is used with a dual-chamber device, the atrialelectrodes may not be in contact with the atrial wall. In this case, the measured depolarization signal hasa relatively low Amplitude and could require a more sensitive setting.• Left ventricular lead configuration. Proper programming of the LV coronary venous Lead Configurationis essential for proper LV lead function. Program the Lead Configuration in accordance with the numberof electrodes on the LV lead; otherwise, erratic LV sensing, loss of LV pacing, or ineffective LV pacingmight occur.• Quadripolar pacing configuration. When an LVRing4>>RV pacing configuration is programmed withan IS4-LLLL lead, the LV tip may be used as the anode rather than the RV ring. When programming tothis configuration, evaluate the pacing threshold and ensure no extracardiac stimulation is present.13
• Left Ventricular Protection Period (LVPP). Use of a long LVPP reduces the maximum LV pacingrate and may inhibit CRT at higher pacing rates.• Sensing adjustment. Following any Sensitivity parameter adjustment or any modification of the sensinglead, always verify appropriate sensing. Programming Sensitivity to the highest value (lowest sensitivity)may result in undersensing of cardiac activity. Likewise, programming to the lowest value (highestsensitivity) may result in oversensing of non-cardiac signals.• Sensitivity in unipolar lead configuration. The amplitude and prevalence of myopotential noise isincreased in unipolar lead configurations, as compared to bipolar lead configurations. For patients with aunipolar lead configuration and myopotential oversensing during activity involving the pectoral muscles,the programming of Fixed Sensitivity is recommended.• Use of Patient Triggered Monitor. Use care when using Patient Triggered Monitor, because thefollowing conditions will exist while it is enabled:• All other magnet features, including asynchronous pacing, are disabled. The Magnet feature willnot indicate magnet position.• Device longevity is impacted. To help reduce the longevity impact, PTM only allows storage of oneepisode, and PTM is automatically disabled after 60 days if data storage was never triggered.• Once the EGM is stored (or 60 days elapses), PTM is disabled and the device Magnet Responseautomatically will be set to Pace Async. However, if a magnet is used, the pulse generator willnot revert to asynchronous operation until the magnet is removed for 3 seconds and placed onthe device again.14
Environmental and Medical Therapy Hazards• Avoid electromagnetic interference (EMI). Advise patients to avoid sources of EMI. The pulsegenerator may inhibit pacing due to oversensing, or may switch to asynchronous pacing at theprogrammed pacing rate or at the magnet rate in the presence of EMI.Moving away from the source of the EMI or turning off the source usually allows the pulse generatorto return to normal operation.Examples of potential EMI sources are:• Electrical power sources, arc welding or resistance welding equipment, and robotic 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 electrical current is passed through the body,such as TENS, electrocautery, electrolysis/thermolysis, electrodiagnostic testing, electromyography,or nerve conduction studies• Any externally applied device that uses an automatic lead detection alarm system (e.g., an EKGmachine)Hospital and Medical Environments• Mechanical ventilators. During mechanical ventilation, respiration-based trending may be misleading;therefore, the Respiratory Sensor should be programmed to Off.15
• Conducted electrical current. Any medical equipment, treatment, therapy, or diagnostic test thatintroduces electrical current into the patient has the potential to interfere with pulse generator function.• External patient monitors (e.g., respiratory monitors, surface ECG monitors, hemodynamicmonitors) may interfere with the pulse generator’s impedance-based diagnostics (e.g., RespiratoryRate trend). To resolve suspected interactions with Respiratory Sensor-based diagnostics,deactivate the pulse generator’s Respiratory Sensor by programming it to Off.• Medical therapies, treatments, and diagnostic tests that use conducted electrical current (e.g.,TENS, electrocautery, electrolysis/thermolysis, electrodiagnostic testing, electromyography, ornerve conduction studies) may interfere with or damage the pulse generator. Program the deviceto Electrocautery Protection Mode prior to the treatment, and monitor device performance duringthe treatment. After the treatment, verify pulse generator function ("Post-Therapy Pulse GeneratorFollow Up" on page 20).•Internaldefibrillation. Do not use internal defibrillation paddles or catheters unless the pulse generatoris disconnected from the leads because the leads may shunt energy. This could result in injury to thepatient and damage to the implanted system.16
• External defibrillation. Itcantakeupto15secondsforsensingto recover after an external shock isdelivered. In non-emergency situations, for pacemaker dependent patients, consider programming thepulse generator to an asynchronous pacing mode and programming the Respiratory Sensor to Off prior toperforming external cardioversion or defibrillation.External defibrillation or cardioversion can damage the pulse generator. To help prevent damage to thepulse generator, consider the following:• Avoid placing a pad (or paddle) directly over the pulse generator. Position the pads (or paddles)as far from the pulse generator as possible.• Position the pads (or paddles) in a posterior-anterior orientation when the device is implanted inthe right pectoral region or an anterior-apex orientation when the device is implanted in the leftpectoral region.• Set energy output of external defibrillation equipment as low as clinically acceptable.Following external cardioversion or defibrillation, verify pulse generator function ("Post-Therapy PulseGenerator Follow Up" on page 20).• Lithotripsy. Extracorporeal shock wave lithotripsy (ESWL) may cause electromagnetic interference withor damage to the pulse generator. If ESWL is medically necessary, consider the following to minimize thepotential for encountering 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 a non-rate-responsiveVVI or VOO mode.• Ultrasound energy. Therapeutic ultrasound (e.g., lithotripsy) energy may damage the pulse generator. Iftherapeutic ultrasound energy must be used, avoid focusing near the pulse generator site. Diagnosticultrasound (e.g., echocardiography) is not known to be harmful to the pulse generator.17
• Electrical interference. Electrical interference or “noise” from devices such as electrocautery andmonitoring equipment may interfere with establishing or maintaining telemetry for interrogating orprogramming the device. In the presence of such interference, move the programmer away fromelectrical devices, and ensure 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 to evaluating informationfrom pulse generator memory.• Radio frequency (RF) interference. RF signals from devices that operate at frequencies near that ofthe pulse generator may interrupt ZIP telemetry while interrogating or programming the pulse generator.This RF interference can be reduced by increasing the distance between the interfering device andthe PRM and pulse generator. Examples of devices that may cause interference in the 916.5 MHzfrequency band include:• Cordless phone handsets or base stations• Certain patient monitoring systems• Central line guidewire insertion. Use caution when inserting guidewires for placement of other typesof central venous catheter systems such as PIC lines or Hickman catheters in locations where pulsegenerator leads may be encountered. Insertion of such guidewires into veins containing leads couldresult in the leads being damaged or dislodged.Home and Occupational Environments• Home appliances. Home appliances that are in good working order and properly grounded do notusually produce enough EMI to interfere with pulse generator operation. There have been reports ofpulse generator disturbances caused by electric hand tools or electric razors used directly over thepulse generator implant site.18
• Magnetic fields. Advise patients that extended exposure to strong (greater than 10 gauss or 1 mTesla)magnetic fields may trigger the magnet feature. Examples of 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 Bingo game• Electronic Article Surveillance (EAS) and Security Systems. Advise patients to avoid lingering nearor leaning against antitheft and security gates or tag readers that include radio frequency identification(RFID) equipment. These systems may be found at the entrances and exits of stores, in public libraries,and in point-of-entry access control systems. These systems are unlikely to affect cardiac device functionwhen patients walk through them at a normal pace. If the patient is near an electronic antitheft, security,or entry control system and experiences symptoms, they should promptly move away from nearbyequipment and inform their doctor.• Cellular phones. Advise patients to hold cellular phones to the ear opposite the side of the implanteddevice. Patients should not carry a cellular phone that is turned on in a breast pocket or on a belt within15 cm (6 inches) of the implanted device since some cellular phones may cause the pulse generator todeliver inappropriate therapy or inhibit appropriate therapy.Follow-up Testing• Pacing threshold testing. If the patient’s condition or drug regimen has changed or device parametershave been reprogrammed, consider performing a pacing threshold test to confirm adequate marginsfor pace capture.19
• Follow-up considerations for patients leaving the country. Pulse generator follow-up considerationsshould be made in advance for patients who plan to travel or relocate post-implant to a country other thanthe country in which their device was implanted. Regulatory approval status for devices and associatedprogrammer software configurations varies by country; certain countries may not have approval orcapability to follow specific products.Contact Boston Scientific, using the information on the back cover, for help in determining feasibility ofdevice follow-up in the patient’s destination country.Explant and Disposal• Incineration. Be sure that the pulse generator is removed before cremation. Cremation and incinerationtemperatures might cause the pulse generator to explode.• Device handling. Before explanting, cleaning, or shipping the device, complete the following actions toprevent 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.SUPPLEMENTAL PRECAUTIONARY INFORMATIONPost-Therapy Pulse Generator Follow UpFollowing any surgery or medical procedure with the potential to affect pulse generator function, you shouldperform a thorough follow-up, which may include the following:• Interrogating the pulse generator with a programmer• Reviewing clinical events and fault codes• Reviewing the Arrhythmia Logbook, including stored electrograms (EGMs)20
• Reviewing real-time EGMs• Testing the leads (threshold, amplitude, and impedance)• Reviewing respiratory sensor-based diagnostics• Verifying battery status• Programming any permanent brady parameter to a new value and then reprogramming it back to thedesired value• Saving all patient data• Verifying the appropriate final programming prior to allowing the patient to leave the clinicMinimizing Pacemaker/S-ICD InteractionThese pulse generators are compatible for use with a Subcutaneous Implantable Cardioverter Defibrillator(S-ICD) when implanted with bipolar leads and programmed to a bipolar pacing configuration.A pacemaker can interact with an S-ICD in the following ways:• If during a tachyarrhythmia the pacemaker is not inhibited and the pacing pulses are detected by therate-sensing circuit of the S-ICD, the S-ICD could interpret the pacing pulses as a normal rhythm. TheS-ICD would not detect the arrhythmia and therefore would not deliver therapy.• Pacemaker failure to sense or to capture could result in two independent signals (intrinsic and pacingpulses) to the S-ICD. This could cause the S-ICD’s rate measurement to be faster than the actual heartrate. As a result, the S-ICD could deliver unnecessary therapy.• If the S-ICD counts both the pacing pulses and the resultant ventricular depolarizations, the S-ICD’s ratemeasurement would be faster than the actual heart rate. This could result in unnecessary S-ICD therapy.21
In Safety Mode, these pulse generators use a unipolar pacing and sensing configuration. Safety Mode iscompatible for use with an S-ICD because the configured parameters mitigate the potential pacemaker andS-ICD interactions as follows:• Sensing is AGC at 0.25 mV. The AGC sensing is able to effectively sense an intrinsic rhythm fasterthan the Safety Mode LRL of 72.5 bpm. As a result, pacing is inhibited and does not interfere withS-ICD tachyarrhythmia detection.• When pacing is necessary, the elevated output of 5.0 V and 1.0 ms reduces the risk of not capturing.• If double detection of the pace pulse and the resulting depolarization were to occur, it would not resultin unnecessary S-ICD therapy provided the S-ICD tachy threshold is more than twice the Safety ModeLRL (145 ppm).To help minimize device-device interaction of a bipolar pacemaker when an S-ICD is already implanted, followthese precautionary measures:• Use bipolar pacing leads with close electrode spacing in both chambers. Significant spacing betweenelectrodes may increase the likelihood that the S-ICD will detect the pacing pulses.• Consider programming the pacemaker to (1) the lowest Amplitude allowable for safe capture in thechronic state, (2) the maximum Sensitivity (the lowest programmable level) while maintaining an adequatesafety margin, and (3) the minimum cardiac rate acceptable for the patient.In addition to the above steps, perform the following testing to assess device-device interaction:• Use the S-ICD features, such as markers, real-time electrograms (EGMs), and/or beeping tones, to helpevaluate potential for pacemaker interaction due to oversensing by the S-ICD.NOTE: If a single chamber pacemaker is implanted with an atrial lead, perform testing in both unipolar andbipolar configurations.22
• Ventricular fibrillation and all of the patient’s ventricular tachycardias should be induced while the S-ICDis activated and the pacemaker is programmed to an asynchronous mode at maximum Amplitude andPulse Width. This should provide the greatest opportunity for inhibition of arrhythmia detection due todetection of pacemaker pacing pulses. The pacemaker leads might have to be repositioned to eliminatedetection of the pacing pulses by the S-ICD.Temporarily deactivate the patient’s S-ICD when (1) evaluating pacing and sensing thresholds, (2) when usingan external temporary pacemaker during implant, and (3) when reprogramming an implanted pacemaker.Following any S-ICD discharge, reinterrogate the pacemaker to ensure that the S-ICD shock did not damagethe pacemaker.If implanting an S-ICD in a patient who has a pacemaker already implanted, refer to the S-ICD manual forimplantation considerations.Refer to the Warnings section for additional information regarding pacemaker and S-ICD interactions.Transcutaneous Electrical Nerve Stimulation (TENS)CAUTION: TENS involves passing electrical current through the body, and may interfere with pulse generatorfunction. If TENS is medically necessary, evaluate the TENS therapy settings for compatibility with the pulsegenerator. The following guidelines may reduce the likelihood of interaction:• Place the TENS electrodes as close together and as far away from the pulse generator and leadsas possible.• Use the lowest clinically-appropriate TENS energy output.• Consider cardiac monitoring during TENS use, especially for pacemaker-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.23
• Do not change TENS settings until you have verified that the new settings do not interfere with pulsegenerator function.If TENS is medically necessary outside the clinical setting (at-home use), provide patients with the followinginstructions:• 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 of consciousness duringTENS use, they should turn off the TENS unit and contact their physician.Follow these steps to use the PRM to evaluate pulse generator function during TENS use:1. Observe real-time EGMs at prescribed TENS output settings, noting when appropriate sensing orinterference occurs.NOTE: Patient triggered monitoring may be used as an additional method to confirm device function duringTENS use.2. When finished, turn off the TENS unit.You should also perform a thorough follow-up evaluation of the pulse generator following TENS, to ensure thatdevice function has not been compromised ("Post-Therapy Pulse Generator Follow Up" on page 20).For additional information, contact Boston Scientific using the information on the back cover.Electrocautery and Radio Frequency (RF) AblationCAUTION: Electrocautery and RF ablation may induce ventricular arrhythmias and/or fibrillation, and maycause asynchronous pacing, inhibition of pacing, and/or a reduction in pulse generator pacing output possiblyleading to loss of capture. RF ablation may also cause ventricular pacing up to the MTR and/or changes inpacing thresholds. Additionally, exercise caution when performing any other type of cardiac ablation procedurein patients with implanted devices.24
If electrocautery or RF ablation is medically necessary, observe the following to minimize risk to the patientand device:• Depending on the pacing needs of the patient, enable the Electrocautery Protection Mode, programto an asynchronous pacing mode, or use a magnet to switch to asynchronous pacing. An option forpatients with intrinsic rhythm is to program the Brady Mode to VVI at a rate below the intrinsic rateto avoid competitive pacing.• Have temporary pacing and external defibrillation equipment available.• Avoid direct contact between the electrocautery equipment or ablation catheters and the pulse generatorand leads. RF ablation close to the lead electrode may damage the lead-tissue interface.• Keep the path of the electrical current as far away as possible from the pulse generator and leads.• If RF ablation and/or electrocautery is performed on tissue near the device or leads, monitor pre- andpost-measurements for sensing and pacing thresholds and impedances to determine the integrity andstability of the system.• For electrocautery, use a bipolar electrocautery system where possible and use short, intermittent, andirregular bursts at the lowest feasible energy levels.• RF ablation equipment may cause telemetry interference between the pulse generator and PRM. Ifdevice programming changes are necessary during an RF ablation procedure, turn off the RF ablationequipment before interrogation.When the procedure is finished, cancel the Electrocautery Protection Mode in order to reactivate the previouslyprogrammed therapy modes.25
Ionizing RadiationCAUTION: It is not possible to specify a safe radiation dosage or guarantee proper pulse generator functionfollowing exposure to ionizing radiation. Multiple factors collectively determine the impact of radiation therapyon an implanted pulse generator, including proximity of the pulse generator to the radiation beam, type andenergy level of the radiation beam, dose rate, total dose delivered over the life of the pulse generator, andshielding of the pulse generator. The impact of ionizing radiation will also vary from one pulse generator toanother and may range from no changes in function to a loss of pacing.Sources of ionizing radiation vary significantly in their potential impact on an implanted pulse generator.Several therapeutic radiation sources are capable of interfering with or damaging an implanted pulse generator,including those used for the treatment of cancer, such as radioactive cobalt, linear accelerators, radioactiveseeds, and betatrons.Prior to a course of therapeutic radiation treatment, the patient’s radiation oncologist and cardiologist orelectrophysiologist should consider all patient management options, including increased follow-up and devicereplacement. Other considerations include:• Maximizing shielding of the pulse generator within the treatment field• Determining the appropriate level of patient monitoring during treatmentEvaluate pulse generator operation during and following the course of radiation treatment to exercise as muchdevice functionality as possible ("Post-Therapy Pulse Generator Follow Up" on page 20). The extent, timing,and frequency of this evaluation relative to the radiation therapy regimen are dependent upon current patienthealth, and therefore should be determined by the attending cardiologist or electrophysiologist.Many pulse generator diagnostics are performed automatically once per hour, so pulse generator evaluationshould not be concluded until pulse generator diagnostics have been updated and reviewed (at least one hourafter radiation exposure). The effects of radiation exposure on the implanted pulse generator may remainundetected until some time following exposure. For this reason, continue to monitor pulse generator functionclosely and use caution when programming a feature in the weeks or months following radiation therapy.26
Elevated PressuresThe International Standards Organization (ISO) has not approved a standardized pressure test for implantablepulse generators that experience hyperbaric oxygen therapy (HBOT) or SCUBA diving. However, BostonScientific developed a test protocol to evaluate device performance upon exposure to elevated atmosphericpressures. The following summary of pressure testing should not be viewed as and is not an endorsement ofHBOT or SCUBA diving.CAUTION: Elevated pressures due to HBOT or SCUBA diving may damage the pulse generator. Duringlaboratory testing, all pulse generators in the test sample functioned as designed when exposed to more than1000 cycles at a pressure up to 5.0 ATA. Laboratory testing did not characterize the impact of elevated pressureon pulse generator performance or physiological response while implanted in a human body.Pressure for each test cycle began at ambient/room pressure, increased to a high pressure level, and thenreturned to ambient pressure. Although dwell time (the amount of time under elevated pressure) may have animpact on human physiology, testing indicated it did not impact pulse generator performance. Pressure valueequivalencies are provided below (Table 1 on page 27).Table 1. Pressure Value EquivalenciesPressure value equivalenciesAtmospheres Absolute 5.0 ATASea water deptha40 m (130 ft)Pressure, absolute 72.8 psiaPressure, gaugeb58.1 psig27
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 attending cardiologist or electrophysiologistshould be consulted to fully understand the potential consequences relative to the patient’s specifichealthcondition. A Dive Medicine Specialist may also be consulted prior to SCUBA diving.More frequent device follow-up may be warranted in conjunction with HBOT or SCUBA diving. Evaluate pulsegenerator operation following high pressure exposure ("Post-Therapy Pulse Generator Follow Up" on page 20).The extent, timing, and frequency of this evaluation relative to the high pressure exposure are dependent uponcurrent patient health, and should be determined by the attending cardiologist or electrophysiologist.If you have additional questions, or would like more detail regarding the test protocol or test results specifictoHBOT or SCUBA diving, contact Boston Scientific using the information on the back cover.POTENTIAL ADVERSE EVENTSBased on the literature and on pulse generator and/or lead implant experience, the following alphabetical listincludes the possible adverse events associated with implantation of products described in this literature:• Air embolism• Allergic reaction• Bleeding• Bradycardia28
• Cardiac tamponade• Chronic nerve damage• Component failure• Conductor coil fracture•Death• Electrolyte imbalance/dehydration• Elevated thresholds•Erosion• Excessive fibrotic tissue growth• Extracardiac stimulation (muscle/nerve stimulation)• Fluid accumulation• Foreign body rejection phenomena• Formation of hematomas or seromas• Heart block• Inability to pace• Inappropriate pacing• Incisional pain• Incomplete lead connection with pulse generator• Infection including endocarditis• Lead dislodgment• Lead fracture• Lead insulation breakage or abrasion• Lead perforation29
• Lead tip deformation and/or breakage• Local tissue reaction• Loss of capture• Myocardial infarction (MI)• Myocardial necrosis• Myocardial trauma (e.g., tissue damage, valve damage)• Myopotential sensing• Oversensing/undersensing• Pacemaker-mediated tachycardia (PMT)• Pericardial rub, effusion• Pneumothorax• Pulse generator migration• Shunting current during defibrillation with internal or external paddles• Syncope• Tachyarrhythmias, which include acceleration of arrhythmias and early, recurrent atrial fibrillation• Thrombosis/thromboemboli• Valve damage• Vasovagal response• Venous occlusion• Venous trauma (e.g., perforation, dissection, erosion)• Worsening heart failurePatients may develop psychological intolerance to a pulse generator system and may experience the following:• Dependency30
•Depression• Fear of premature battery depletion• Fear of device malfunctionAdditionally, potential adverse events associated with the implantation of a coronary venous lead systeminclude:• Allergic reaction to contrast media• Breakage/failure of implant instruments• Prolonged exposure to fluoroscopic radiation• Renal failure from contrast media used to visualize coronary veinsMECHANICAL SPECIFICATIONSThe following mechanical specifications and material specifications apply to VALITUDE devices.All VALITUDE models have a case electrode surface area of 35.05 cm² and all VALITUDE X4 models havea case electrode surface area of 34.58 cm². Usable battery capacity is 1.6 Ah and residual usable batterycapacity at Explant is 0.10 Ah.Mechanical specifications specific to each model are listed below.31
Table 2. Mechanical Specifications - VALITUDE CRT-PsModel DimensionsWxHxD(cm)Mass (g) Volume (cm3) Connector TypeU125 4.45 x 6.13 x 0.75 30.6 16.2 RA:IS-1;RV:IS-1;LV: IS-1U128 4.45 x 6.17 x 0.75 33.0 17.6 RA:IS-1;RV:IS-1;LV: IS4VALITUDE devices include ZIP telemetry operating with a transmit frequency of 402 to 405 MHz.Material specifications are shown below:• Case: hermetically sealed titanium• Header: implantation-grade polymer• Power Supply (VALITUDE): lithium-carbon monofluoride cell; Boston Scientific; 402294The following mechanical specifications and material specifications apply to INTUA and INVIVE devices.All INTUA and INVIVE models have a case electrode surface area of 35.98 cm². Usable battery capacity is1.45 Ah and residual usable battery capacity at Explant is 0.09 Ah.Mechanical specifications specific to each model are listed below.32
Table 3. Mechanical Specifications - INTUA CRT-PsModel DimensionsWxHxD(cm)Mass (g) Volume (cm3) Connector TypeV272 4.45 x 6.10 x 0.75 34.0 15.0 RA: IS-1, RV: IS-1,LV: LV-1V273 4.45 x 6.10 x 0.75 34.0 15.0 RA: IS-1, RV: IS-1,LV: IS-1Table 4. Mechanical Specifications - INVIVE CRT-PsModel DimensionsWxHxD(cm)Mass (g) Volume (cm3) Connector TypeV172 4.45 x 6.10 x 0.75 34.0 15.0 RA:IS-1,RV:IS-1,LV: LV-1V173 4.45 x 6.10 x 0.75 34.0 15.0 RA:IS-1,RV:IS-1,LV: IS-1INTUA and INVIVE devices include ZIP telemetry operating with a transmit frequency of 916.5 MHz.Material specifications are shown below:• Case: hermetically sealed titanium• Header: implantation-grade polymer• Power Supply (INTUA and INVIVE): lithium-manganese dioxide cell; Boston Scientific; 40212533
ITEMS INCLUDED IN PACKAGEThe following items are included with the pulse generator:• One torque wrench• Product literatureNOTE: Accessories (e.g., wrenches) are intended for one-time use only. They should not be resterilizedor reused.SYMBOLS ON PACKAGINGThe following symbols may be used on packaging and labeling (Table 5 on page 34):Table 5. Symbols on packagingSymbol DescriptionReference numberPackage contentsPulse generator34
Table 5. Symbols on packaging (continued)Symbol DescriptionTorque wrenchLiterature enclosedSerial numberUse byLot numberDate of manufactureSterilized using ethylene oxide35

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