Overview

Boston Scientific CRM pursues product quality and reliability with a passion. We therefore continuously monitor product performance to make improvements whenever possible. The following tables provide a count and description of worldwide malfunctions associated with the majority of actively in-service Boston Scientific products. Intermedics co-branded product data are included in corresponding pacemaker and pacing lead malfunction counts and details. Information presented is based on malfunctions reported to and analyzed by Boston Scientific. Each table contains malfunction counts listed by category, pattern and therapy availability.

Category

Malfunctions are categorized by the nature of their root cause. For example, a malfunction due to the software within a pulse generator is listed in the Software category. There are four pulse generator malfunction categories, three malfunction categories for leads reported with previous methodology, and five malfunction categories for leads reported with AdvaMed methodology (described below).

Patterns

Patients and physicians have asked for more access to Quality System details; therefore, we provide information on patterns of product performance. Patterns listed are informational and do not represent actions that need to be taken. Boston Scientific is committed to direct communication when predicted product performance fails to achieve design or performance expectations or when actions may be taken to improve patient outcomes. Malfunctions associated with product advisories are denoted. Refer to the Product Advisories section for more information.

Each pattern description is comprised of the following components:

• Clinical Manifestation and Root Cause – Malfunctions for each product are characterized according to root cause. Descriptions provide clinical observations and/or analysis findings associated with each malfunction pattern listed in this report. Malfunctions listed within “Other” either do not yet have an identified root cause, or are related to a proprietary product feature, such as connectors or seal rings.
• Improvement Implementation – All of the patterns listed are thoroughly investigated and analyzed. As part of Boston Scientific's process of continuous improvement, when possible, improvements have been or will be implemented in response to identified malfunction patterns. Improvements may include product design changes in existing or subsequent generations, manufacturing process modifications, software updates, educational communications or labeling changes. Improvement implementation may vary by geography due to various factors, including regulatory review timing, and may not completely mitigate or eliminate the potential for additional malfunctions.

Pattern information in this report is dynamic. Pattern names, superscript number assignments and descriptions may all change from quarter to quarter; as Boston Scientific's investigations progress and improvements are implemented, updated information is provided.

Therapy Availability

Malfunctions are further classified according to their impact on therapy, as follows:

• Malfunction With Compromised Therapy – The condition when a device is confirmed through laboratory analysis to have malfunctioned in a manner that compromised pacing or defibrillation therapy (including complete loss or partial degradation) while implanted and in service. Examples include (but are not limited to): sudden loss of battery voltage; accelerated current drain such that low battery was not detected before loss of therapy; sudden malfunction during defibrillation therapy resulting in aborted therapy delivery; intermittent malfunction in which therapy is compromised while in the malfunction state.
• Malfunction Without Compromised Therapy – The condition when a device is confirmed through laboratory analysis to have malfunctioned in a manner that did not compromise pacing or defibrillation therapy while implanted and in service. Malfunctions in which critical patient-protective pacing and defibrillation therapies remain available are included here. Examples include (but are not limited to): error affecting diagnostic functions, telemetry function, data storage; malfunction of a component that causes the battery to lose power quickly enough to result in premature battery depletion, but slowly enough that the condition is detected through normal follow-up before therapy is lost; mechanical problems with connector header that do not affect therapy.

For lead malfunctions listed in the Extrinsic Factors category, therapy availability may be known, not reported or unable to be determined. When known, these malfunctions are reported in the appropriate therapy availability column. When unknown, because the lead was taken out of service and returned, it is assumed that therapy may have been compromised, and will be reported in the With Compromised Therapy column.

Pulse Generator Confirmed Malfunctions

Pulse generator confirmed malfunctions represent devices removed from service and confirmed through laboratory analysis to have operated outside the performance limits established by Boston Scientific while implanted and in service. Device damage occurring during or after explant, or caused by external factors including those warned against in product labeling (e.g. therapeutic radiation), are not considered device malfunctions. Damage to a pulse generator caused by a lead malfunction is reported as a lead malfunction.

Lead Malfunctions

The Boston Scientific Product Performance Report is in compliance with the May 2009 AdvaMed This methodology also addresses the Recommendations from the Heart Rhythm Society Task Force on Lead Performance Policies and Guidelines. The reporting methodology outlined in the AdvaMed Guidance has been applied to all lead families currently being implanted as of May 2009, and will be applied to all future lead families as they are included in the PPR. Lead families which will now be reported using AdvaMed Guidance methodology include: all Cardiac Resynchronization Therapy leads, all Reliance leads, all Flextend and Fineline II leads. All other leads will continue to be reported using previous methodology and categorization.

Malfunction Categories for Currently Implanted Leads

These malfunction categories include Conductor Fracture, Insulation Breach, Crimps/Welds/Bonds, Other and Extrinsic Factors, and include the following:

• Conductor Fracture: conductor break with complete or intermittent loss of continuity that could interrupt current flow (e.g. fractured conductors), including those associated with clavicle flex fatigue or crush damage.
• Insulation Breach: Any lead insulation breach. Examples include: 1) proximal abrasions associated with lead-on-lead or lead-on-PG contact in the pocket, 2) mid-lead insulation damage caused by clavicle flex fatigue or crush, suture or suture sleeve, insulation wear in the region of vein insertion, and 3) distal region wear due to lead-on-lead (intracardiac), lead-on-heart valve or lead-on-other anatomy contact.
• Crimps/Welds/Bonds: Any interruption in the conductor or lead body associated with a point of connection. Typically demonstrated by high or low shocking/pacing impedance, undersensing or oversensing.
• Other: Includes specific proprietary lead mechanical attributes, such as lead-incorporated sensors, connectors, seal rings or the 4–Site connector, or malfunction modes not included in the three categories above.
• Extrinsic Factors: Lead complication where the identified lead was removed from service and returned for analysis, where analysis was either inconclusive or the complication was not confirmed. Inconclusive includes leads where only portions of the lead were available for return, or the returned lead was damaged by the explantation process. Unconfirmed includes when lab analysis could not determine an out of specification condition (including complaints of malfunction or complications such as dislodgements, perforations or failure to capture).

The categories of Conductor, Insulation, Crimps/Welds/Bonds and Other represent malfunctions for leads removed from service and confirmed through laboratory analysis to have operated outside the performance limits established by Boston Scientific while implanted and in service. The Extrinsic Factors category represents malfunctions for leads with reported complications for which the leads were removed from service, but for which laboratory analysis was inconclusive or the complication was unconfirmed. For the Extrinsic Factors category only, malfunctions are included for leads implanted greater than 30 days.