PUNCTUA™, ENERGEN™, INCEPTA™ Physicians Technical Manual

Table of Contents Device Description... 1 Related Information ... 4 Indications and Usage ... 4 Contraindications... 4 Warnings ... 5 Precautions... 8 Supplemental Precautionary Information ... 25 Post-Therapy Pulse Generator Follow Up... 25 Transcutaneous Electrical Nerve Stimulation (TENS)... 27 Electrocautery and Radio Frequency (RF) Ablation ... 29 Ionizing Radiation... 31 Elevated Pressures ... 32 Potential Adverse Events ... 35 Mechanical Specifications ... 38 Items Included in Package ... 40 Symbols on Packaging ... 41 Characteristics as Shipped... 45 X-Ray Identifier... 47 Pulse Generator Longevity ... 48 Warranty Information ... 51 Product Reliability... 51 Patient Counseling Information ... 52

Patient Handbook... Lead Connections... Implanting the Pulse Generator... Step A: Check Equipment... Step B: Interrogate and Check the Pulse Generator ... Step C: Implant the Lead System ... Step D: Take Baseline Measurements... Step E: Form the Implantation Pocket ... Step F: Connect the Leads to the Pulse Generator... Step G: Evaluate Lead Signals... Step H: Program the Pulse Generator... Step I: Test for Ability to Convert Ventricular Fibrillation and Inducible Arrhythmias ... Step J: Implant the Pulse Generator... Step K: Complete and Return the Implantation Form... Bidirectional Torque Wrench... Follow Up Testing ... Predischarge Follow Up ... Routine Follow Up ... Explantation...

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Boston Scientific Corporation acquired Guidant Corporation in April 2006. During our transition period, you may see both the Boston Scientific and Guidant names on product and patient material. As we work through the transition, we will continue to offer doctors and their patients technologically advanced and high quality medical devices and therapies. DEVICE DESCRIPTION This manual contains information about the PUNCTUA, ENERGEN, and INCEPTA families of cardiac resynchronization therapy defibrillators (CRT-Ds) (specific models are listed in "Mechanical Specifications" on page 38). Therapies These pulse generators have a small, thin, physiologic shape that minimizes pocket size and may minimize device migration. They provide a variety of therapies, including: •

Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death (SCD) such as VT and VF

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Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation

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Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy 1

Cardioversion/defibrillation therapies include: •

A range of low- and high-energy shocks using a biphasic waveform

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The choice of multiple shock vectors: –

Distal shock electrode to proximal shock electrode and pulse generator case (TRIAD electrode system)

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Distal shock electrode to proximal shock electrode (RV Coil to RA Coil)

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Distal shock electrode to pulse generator case (RV Coil to Can)

Leads The pulse generator has independently programmable outputs and accepts one or more of the following leads, depending on the model: •

One IS-11 atrial lead

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One IS-1 coronary venous pace/sense lead

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One LV-1 coronary venous pace/sense lead

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One DF-1/IS-12 cardioversion/defibrillation lead

1. 2.

IS-1 refers to the international standard ISO 5841-3:2000. DF-1 refers to the international standard ISO 11318:2002.

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One DF4-LLHH or DF4-LLHO3 multipolar connector cardioversion/defibrillation lead

Leads with either a GDT-LLHH/LLHO or DF4-LLHH/LLHO label are equivalent and are compatible with a device containing either a GDT-LLHH or DF4-LLHH port. The pulse generator and the leads constitute the implantable portion of the pulse generator system. PRM System These pulse generators can be used only with the ZOOM LATITUDE Programming System, which is the external portion of the pulse generator system and includes: •

Model 3120 Programmer/Recorder/Monitor (PRM)

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Model 2868 ZOOMVIEW Software Application

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Model 6577 Accessory Telemetry Wand

You can use the PRM system to do the following: •

Interrogate the pulse generator

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Program the pulse generator to provide a variety of therapy options

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Access the pulse generator’s diagnostic features

3.

DF4 refers to the international standard ISO 27186:2010. 3

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Perform noninvasive diagnostic testing

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Access therapy history data

RELATED INFORMATION Refer 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 instructions specific to the chosen lead configurations. Refer to the PRM system Operator’s Manual for specific information about the PRM such as setup, maintenance, and handling. INDICATIONS AND USAGE Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Boston Scientific CRT-Ds are also indicated for reduction of symptoms of moderate to severe heart failure (NYHA III/IV) in patients who remain symptomatic despite stable, optimal heart failure drug therapy, and have left ventricular dysfunction (EF ≤ 35%) and QRS duration ≥ 120 ms. CONTRAINDICATIONS There are no contraindications for this device. 4

WARNINGS General •

Labeling knowledge. Read this manual thoroughly before implantation to avoid damage to the pulse generator and/or lead. Such damage can result in patient injury or death.

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For single patient use only. Do not reuse, reprocess, or resterilize. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device 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 risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness, or death of the patient.

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Backup defibrillation protection. Always have external defibrillation protection available during implant. If not terminated in a timely fashion, an induced ventricular tachyarrhythmia can result in the patient’s death.

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Resuscitation availability. Ensure that an external defibrillator and medical personnel skilled in CPR are present during post-implant device testing should the patient require external rescue. 5

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Patch leads. Do not use defibrillation patch leads with the pulse generator system, or injury to the patient may occur.

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Separate pulse generator. Do not use this pulse generator with another pulse generator. This combination could cause pulse generator interaction, resulting in patient injury or a lack of therapy delivery.

Handling •

Avoid shock during handling. Program the pulse generator Tachy Mode(s) to Off during implant, explant, or postmortem procedures to avoid inadvertent high voltage shocks.

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Do not kink leads. Do not kink, twist, or braid the lead with other leads as doing so could cause lead insulation abrasion damage or conductor damage.

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Handling the lead without Connector Tool. For DF4-LLHH or DF4-LLHO leads, use caution handling the lead terminal when the Connector Tool is not present on the lead. Do not directly contact 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, possibly compromising the sealing integrity and result in loss of therapy or inappropriate therapy, such as a high voltage short within the header.

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Handling the terminal while tunneling. Do not contact any other portion of the DF4-LLHH or DF4-LLHO 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 atrial tachyarrhythmias. Tracking of atrial arrhythmias could result in VT or VF.

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Atrial-only modes. Do not use atrial-only modes in patients with heart failure because such modes do not provide CRT.

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Ventricular sensing. Left ventricular lead dislodgement to a position near the atria can result in atrial oversensing and left ventricular pacing inhibition.

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Slow VT. Physicians should use medical discretion when implanting this device in patients who present with slow VT. Programming therapy for slow monomorphic VT may preclude CRT delivery at faster rates if these rates are in the tachyarrhythmia zones.

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Post-Implant •

Protected environments. Advise patients to seek medical guidance before entering environments that could adversely affect the operation of the active implantable medical device, including areas protected by a warning notice that prevents entry by patients who have a pulse generator.

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Magnetic Resonance Imaging (MRI) exposure. Do not expose a patient to MRI device scanning. Strong magnetic fields may damage the pulse generator and/or lead and cause injury to the patient.

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Diathermy. Do not subject a patient with an implanted pulse generator and/or lead to diathermy since diathermy may cause fibrillation, burning of the myocardium, and irreversible damage to the pulse generator because of induced currents.

PRECAUTIONS Clinical Considerations •

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Pacemaker-mediated tachycardia (PMT). Retrograde conduction combined with a short PVARP might induce PMT.

Sterilization and Storage •

If package is damaged. The blister trays and contents are sterilized with ethylene oxide gas before final packaging. When the pulse generator and/or lead is received, it is sterile provided the container is intact. If the packaging is wet, punctured, opened, or otherwise damaged, return the pulse generator and/or lead to Boston Scientific.

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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 communication capabilities, programming or implanting the device because temperature extremes may affect initial device function.

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Device storage. Store the pulse generator in a clean area away from magnets, kits containing magnets, and sources of EMI to avoid device damage.

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Use by date. Implant the pulse generator and/or lead before or on the USE BY date on the package label because this date reflects a validated shelf life. For example, if the date is January 1, do not implant on or after January 2.

Implantation •

Expected benefits. Determine whether the expected device benefits outweigh the possibility of early device replacement for patients whose tachyarrhythmias require frequent shocks. 9

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Evaluate patient for surgery. There may be additional factors regarding the patient’s overall health and medical condition that, while not related to device function or purpose, could render the patient a poor candidate for implantation of this system. Cardiac health advocacy groups may have published guidelines that may be helpful in conducting this evaluation.

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Lead compatibility. Prior to implantation, confirm the lead-to-pulse generator compatibility. Using incompatible leads and pulse generators can damage the connector and/or result in potential adverse consequences, such as undersensing of cardiac activity or failure to deliver necessary therapy.

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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.

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Line-powered equipment. Exercise extreme caution if testing leads using line-powered equipment because leakage current exceeding 10 µA can induce ventricular fibrillation. Ensure that any line-powered equipment is within specifications.

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Replacement device. Implanting a replacement device in a subcutaneous pocket that 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 pocket air entrapment and insufficient grounding. Suturing the device in place reduces the possibility of migration and erosion.

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Do not bend the lead near the lead-header interface. Insert the lead terminal straight into the lead port. Do not bend the lead near the lead-header interface. Improper insertion can cause insulation or connector damage.

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Absence of a lead. The absence of a lead or plug in a lead port may affect device performance. 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.

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Electrode connections. Do not insert a lead into the pulse generator connector without taking the following precautions to ensure proper lead insertion: •

Insert the torque wrench into the preslit depression of the seal plug before inserting the lead into the port, to release any trapped fluid or air.

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Visually verify that the setscrew is sufficiently retracted to allow insertion. Use the torque wrench to loosen the setscrew if necessary.

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Fully insert each lead into its lead port and then tighten the setscrew onto the terminal pin.

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Defibrillation lead impedance. If total shocking lead impedance during implant is less than 20 Ω, verify the proximal coil is not in contact with the pulse generator surface. A measurement of less than 20 Ω is an indication of a short somewhere in the system. If repeated measurements show the total shocking lead impedance is less than 20 Ω, the lead and/or pulse generator may need to be replaced.

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Shunting energy. Do not allow any object that is electrically conductive to come into 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 implanted system.

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Do not suture directly over lead. Do not suture directly over the lead body, as this may cause structural damage. Use the suture sleeve to secure the lead proximal to the venous entry site to prevent lead movement.

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Respiratory Sensor. Do not program the Respiratory Sensor to On until after the pulse generator has been implanted and system integrity has been tested and verified.

Device Programming •

Device communication. Use only the designated PRM and software application to communicate with this pulse generator.

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STAT PACE settings. When a pulse generator is programmed to STAT PACE settings, it will continue to pace at the high-energy STAT PACE values if it is not reprogrammed. The use of STAT PACE parameters will decrease device longevity.

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Biventricular pacing therapy. This device is intended to provide biventricular or left ventricular pacing therapy. Programming the device to provide RV-only pacing is not intended for the treatment of heart failure. The clinical effects of RV-only pacing for the treatment of heart failure have not been established.

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Pacing and sensing margins. Consider lead maturation in your choice of pacing amplitude, pacing pulse width, and sensitivity settings. •

An acute pacing threshold greater than 1.5 V or a chronic pacing threshold greater than 3 V can result in loss of capture because thresholds may increase over time.

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An R-wave amplitude less than 5 mV or a P-wave amplitude less than 2 mV can result in undersensing because the sensed amplitude may decrease after implantation.

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Pacing lead impedance should be within the range of 200 Ω and 2000 Ω.

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Proper programming of the lead configuration. If the Lead Configuration is programmed to Bipolar when a unipolar lead is implanted, pacing will not occur.

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Proper programming of the shock vector. If the shock vector is programmed to RVcoil>>RAcoil and the lead does not have an RA coil, shocking will not occur.

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Programming for supraventricular tachyarrhythmias (SVTs). Determine if the device and programmable options are appropriate for patients with SVTs because SVTs can initiate unwanted device therapy.

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AV Delay. To ensure a high percentage of biventricular pacing, the programmed AV Delay setting must be less than the patient’s intrinsic PR interval.

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Adaptive-rate pacing. Adaptive-rate pacing should be used with care in patients who are unable to tolerate increased pacing rates.

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Ventricular refractory periods (VRPs) in adaptive-rate pacing. Adaptive-rate pacing is not limited by refractory periods. A long refractory period programmed in combination with a high MSR can result in asynchronous pacing during refractory periods since the combination can cause a very small sensing window or none at all. Use dynamic AV Delay or dynamic PVARP to optimize sensing windows. If you are entering a fixed AV delay, consider the sensing outcomes.

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Atrial Tachy Response (ATR). ATR should be programmed to On if the patient has a history of atrial tachyarrhythmias. The delivery of CRT is compromised because AV synchrony is disrupted if the ATR mode switch occurs.

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Threshold test. During the LV threshold test, RV backup pacing is unavailable.

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Left ventricular pacing only. The clinical effect of LV pacing alone for heart failure patients has not been studied.

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Shock waveform polarity. For IS-1/DF-1 leads, never change the shock waveform polarity by physically switching the lead anodes and cathodes in the pulse generator header-use the programmable Polarity feature. Device damage or nonconversion of the arrhythmia post-operatively may result if the polarity is switched physically. 15

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Tachy Mode to Off. To prevent inappropriate shocks, ensure that the pulse generator’s Tachy Mode is programmed to Off when not in use and before handling the device. For tachyarrhythmia detection and therapy, verify that the Tachy Mode is programmed to Monitor +Therapy.

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Atrial oversensing. Take care to ensure that artifacts from the ventricles are not present on the atrial channel, or atrial oversensing may result. If ventricular artifacts are present in the atrial channel, the atrial lead may need to be repositioned to minimize its interaction.

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ATR entry count. Exercise care when programming the Entry Count to low values in conjunction with a short ATR Duration. This combination allows mode switching with very few fast atrial beats. For example, if the Entry Count was programmed to 2 and the ATR Duration to 0, ATR mode switching could occur on 2 fast atrial intervals. In these instances, a short series of premature atrial events could cause the device to mode switch.

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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 atrial undersensing could cause termination of mode switching.

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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 be consistent with the number and type of leads actually in use.

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Left ventricular lead configuration. Proper programming of the LV coronary venous lead configuration is essential for proper LV lead function. Program the lead configuration in accordance with the number of electrodes on the LV lead; otherwise, erratic LV sensing, loss of LV pacing, or ineffective LV pacing might occur.

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Left Ventricular Protection Period (LVPP). Use of a long LVPP reduces the maximum LV pacing rate and may inhibit CRT at higher pacing rates.

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Sensing adjustment. Following any sensing range adjustment or any modification of the sensing lead, always verify appropriate sensing. Programming Sensitivity to the highest value (lowest sensitivity) may result in delayed detection or undersensing of cardiac activity.

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