Advantio Physicians Technical Manual

Table of Contents Device Description... 1 Related Information ... 3 Indications and Usage ... 3 Contraindications... 4 Warnings ... 5 Precautions... 8 Supplemental Precautionary Information ... 27 Post-Therapy Pulse Generator Follow Up... 27 Transcutaneous Electrical Nerve Stimulation (TENS)... 29 Electrocautery and Radio Frequency (RF) Ablation ... 31 Ionizing Radiation... 33 Elevated Pressures ... 34 Potential Adverse Events ... 37 Mechanical Specifications ... 39 Items Included in Package ... 41 Symbols on Packaging ... 42 Characteristics as Shipped... 46 X-Ray Identifier... 48 Pulse Generator Longevity ... 49 Warranty Information ... 55 Product Reliability... 55 Patient Counseling Information ... 56

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: Implant the Pulse Generator ... Step J: 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 ADVANTIO family of implantable pacemakers, including the following types of pulse generators (specific models are listed in "Mechanical Specifications" on page 39): •

SR-single chamber pacemaker providing ventricular or atrial pacing and sensing

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DR-dual-chamber pacemaker providing ventricular and atrial pacing and sensing

Therapies These pulse generators provide bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias. Leads The pulse generator has independently programmable outputs and accepts one or more of the following leads, depending on the model:

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One IS-11 unipolar or bipolar atrial lead

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One IS-1 unipolar or bipolar right ventricular lead NOTE: Single-chamber devices will accept either an IS-1 atrial or an IS-1 ventricular lead.

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 2869 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

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

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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 pacemakers are indicated for treatment of the following conditions: •

Symptomatic paroxysmal or permanent second- or third-degree AV block

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Symptomatic bilateral bundle branch block

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Symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial [SA] block

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Bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias

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Neurovascular (vaso-vagal) syndromes or hypersensitive carotid sinus syndromes

Adaptive-rate pacing is indicated for patients exhibiting chronotropic incompetence and who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or level of physical activity. Dual-chamber and atrial tracking modes are also indicated for patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of the following: •

Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block

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VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm

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Low cardiac output or congestive heart failure secondary to bradycardia

CONTRAINDICATIONS These Boston Scientific pacemakers are contraindicated in patients who have a separate implanted cardioverter-defibrillator (ICD). 4

Use of certain pacing modes and/or features available in these Boston Scientific pacemakers is contraindicated for the following patients under the circumstances listed: •

Minute ventilation in patients with both unipolar atrial and ventricular leads

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Single-chamber atrial pacing in patients with impaired AV nodal conduction

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Atrial tracking modes for patients with chronic refractory atrial tachyarrhythmias (atrial fibrillation or flutter), which might trigger ventricular pacing

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Dual-chamber and single-chamber atrial pacing in patients with chronic refractory atrial tachyarrhythmias

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Asynchronous pacing in the presence (or likelihood) of competition between paced and intrinsic rhythms

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 and electrophysiologic testing. If not terminated in a timely fashion, an induced ventricular tachyarrhythmia can result in the patient’s death.

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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.

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Safety Core operation. In response to applicable nonrecoverable or repeat fault conditions, the pulse generator will switch irreversibly to Safety Core operation. Safety Core pacing is unipolar, which is contraindicated for patients with an ICD.

Handling • 6

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.

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 ventricular tachyarrhythmias.

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Lead safety switch programmed to On. In devices with the lead safety switch programmed to On, the lead polarity will switch to unipolar in the presence of a lead impedance of ≤ 200 or ≥ 2000 Ω. Unipolar pacing is contraindicated for patients with an ICD.

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Sensitivity settings and EMI. If programmed to a fixed atrial sensitivity value of 0.15 mV, the pulse generator may be more susceptible to electromagnetic interference. This increased susceptibility should be taken into consideration when determining the follow-up schedule for patients requiring such a setting.

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 scanning. Strong magnetic fields may damage the pulse generator and/or lead system, possibly resulting in injury to or death of 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 •

STAT PACE. STAT PACE will initiate unipolar pacing.

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Pacemaker-mediated tachycardia (PMT). Programming minimum PVARP less than retrograde V–A conduction may increase the likelihood of a PMT.

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Automatic Capture. Automatic Capture is intended for ventricular use only. Do not program Amplitude to Auto for single-chamber devices implanted in the atrium.

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MV sensor modes. The safety and efficacy of the MV sensor modes have not been clinically established in patients with abdominal implant sites.

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MV sensor mode performance. MV sensor performance may be adversely affected under transient conditions such as pneumothorax, pericardial effusion, or pleural effusion. Consider programming the MV sensor Off until these conditions are resolved.

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Adaptive-rate modes. Adaptive-rate modes based completely or in part on MV might be inappropriate for patients who can achieve respiratory cycles shorter than one second (greater than 60 breaths per minute). Higher respiration rates attenuate the impedance signal, which diminishes the MV rate response (i.e., the pacing rate will drop toward the programmed LRL). Adaptive-rate modes based completely or in part on MV should not be used for patients with: •

An ICD

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Unipolar leads-for MV detection, a bipolar lead is required in either the atrium or ventricle

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Epicardial ventricular leads-MV measurement has only been tested with a bipolar transvenous lead

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A mechanical ventilator-use of the ventilator might result in an inappropriate MV sensor-driven rate

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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 •

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Expected benefits. Determine whether the expected device benefits provided by programmable options outweigh the possibility of more rapid battery depletion.

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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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Dual chamber device without a functional RV lead. If a dual-chamber device 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 in undersensing or oversensing.

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

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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 likely decrease device longevity.

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

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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.

Lead impedance values and Lead Safety Switch. If leads with measured impedance values approaching 200 or 2000 Ω are used, consider programming Lead Safety Switch Off.

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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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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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Adaptive-rate pacing. Rate adaptive 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 to optimize sensing windows. If you are entering a fixed AV delay, consider the sensing outcomes.

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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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MV Recalibration. To obtain an accurate MV baseline, the MV sensor will be calibrated automatically or can be calibrated manually. A new, manual calibration should be performed if the pulse generator is removed from the pocket following implant, such as during a lead repositioning procedure, or in cases where the MV baseline may have been affected by factors such as lead maturation, air entrapment in the pocket, pulse generator motion due to inadequate suturing, external defibrillation or cardioversion, or other patient complications (e.g., pneumothorax).

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Sensing adjustment. Following any Sensitivity parameter adjustment or any modification of the sensing lead, 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 (highest sensitivity) may result in oversensing of non-cardiac signals.

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Sensitivity in unipolar lead configuraton. The amplitude and prevalence of myopotential noise is increased in unipolar lead configurations, as compared to bipolar lead configurations. For patients with a unipolar lead configuration and myopotential oversensing during activity involving the pectoral muscles, the programming of Fixed Sensitivity is recommended.

Environmental and Medical Therapy Hazards •

Avoid electromagnetic interference (EMI). Advise patients to avoid sources of EMI. The pulse generator may inhibit pacing due to oversensing, or may switch to asynchronous pacing at the programmed 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 generator to return to normal operation.

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