Introduction to Product Performance eSource

For 40 years, Medtronic has monitored performance via both returned product analysis and multicenter clinical studies.

The Product Performance eSource (PPeS) presents device survival estimates, advisory summaries, performance notes, and other information pertinent to assessing the performance of Medtronic implantable pulse generators (IPGs), implantable cardioverter defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices, insertable cardiac monitors (ICMs), and implantable pacing and defibrillation leads.

This Product Performance Report has been prepared in accordance with International Standard ISO 5841-2:2000(E). As Transcatheter Pacing Systems (TPS) combine the pacing functions of an IPG with the therapy delivery functions of an implantable lead into a single device implanted inside the heart, TPS is subject to complications similar to pacing leads and malfunctions or battery depletion events similar to an implanted pulse generator (IPG). The TPS performance report has been developed to align with these guidelines to the extent possible due to the unique difference between TPS compared to a typical implantable device or lead.

The survival estimates provided in this report are considered to be representative of worldwide performance.

Survival Estimates

Medtronic, like other companies, monitors CRT, ICD, and IPG device performance using returned product analysis. We also monitor CRT, ICD, and IPG device performance using an active multicenter clinical study.

Returned product analysis is a passive approach to assessing product performance. This approach provides a suitable measure of product performance only when a significant number of explanted products are returned to the manufacturer. Returned product analysis provides a measure of hardware performance, but not necessarily the total clinical performance (e.g., the incidence of complications such as infection, erosion, muscle stimulation, etc. are not estimated).

The survival estimates provided in this report for CRT, ICD, and IPG devices are based on returned product analysis. This approach is suitable because a significant number of explanted generators are returned for analysis.

Lead performance is monitored differently. In contrast to CRT, ICD, and IPG devices, a very small percentage of leads are returned to the manufacturer due to the difficulty of explanting them. For leads, an active clinical study provides more accurate survival estimates compared to estimates based solely on returned product analysis.

Survival estimates for leads are based on clinical observations recorded via Medtronic’s PAN Registry. This multicenter clinical study is designed to record clinical observations representative of the total clinical experience. Therefore, the lead survival estimates include both lead hardware failure and lead-related medical complications, and do not differentiate a lead hardware failure from other clinical events such as exit block, perforation, dislodgement, or concurrent pulse generator failure.

Transcatheter Pacing Systems are monitored differently. Transcatheter pacing systems (TPS) combine the pacing functions of an IPG with the therapy delivery functions of an implantable lead into a single device implanted inside the heart. To account for the shortfalls of returned product analysis due to a very small percentage of devices being returned, a study of de-identified product data on the Medtronic CareLink™ network is used. The number of devices enrolled and transmitting actively enables a population large enough to give a representative volume of normal battery depletions and to provide insight into the complications that may occur after the device was successfully implanted. TPS survival estimates include both product failures and device-related medical complications and do not differentiate product failures from these complications such as perforation, dislodgement or elevated pacing thresholds.

ICD Charge Times

Since May 2000, Medtronic has provided important information on charge time performance of ICDs. The information provided in this report shows how ICD charge time can vary during the time a device is implanted. The information is presented in graphical format showing charge time as a function of implant time. The data for charge times are collected from devices enrolled in the PAN Registry.

Customer Communications - Advisory Summaries

The Product Performance eSource includes summaries of all Customer Communications classified as Advisories applicable to the performance of the products included in the report. An advisory is added to the report when any product affected by the advisory remains in service and at risk of experiencing the behavior described in the advisory. The advisory will remain in the report until Medtronic estimates no product affected by the advisory remains active, or the risk of experiencing the behavior described in the advisory has passed.

For most advisories, the products subject to the advisory retain essentially the same survival probability as the products of the same model(s) not affected by the advisory. For those advisories where the survival probabilities of the affected and non-affected populations do differ significantly, Medtronic will provide separate survival data for each population. The separate survival data will remain in the report until Medtronic estimates no affected product remains in active service.

Customer Communications - Performance Notes

This report concludes with a number of Customer Communications classified as Non-Advisory Performance Notes developed by Medtronic to provide additional product performance information relevant to follow-up practice and patient management.

Customer Communications - Product Education Briefs

These communications are educational in nature and typically elaborate on information found in the Instructions for Use (IFU) or other approved labeling materials. A product education brief typically serves to clarify information found in labeling that may be misunderstood or misinterpreted by physicians or healthcare professionals. Product education briefs do not provide new patient management guidance, but may be used to reinforce existing recommendations already discussed in the IFU.

Serial Number Lookup Tool

The "Search for Information by Serial Number" tool provides a way to locate information specific to an individual serial number. To obtain accurate results, the serial number must be entered accurately. This tool provides results only for current Cardiac Rhythm Management (CRM) implantable IPG, ICD and CRT devices and leads. While Product Performance eSource has information on hundreds of Medtronic CRM implantable products, it may not include older products, or very new products, or some low volume products.

The serial number lookup tool will provide:

  • A link to the performance information for the product model, if available
  • Links to applicable active Customer Communications, if any
  • A brief status of analysis, if your product has been explanted and returned to our analysis lab

How You Can Help

Medtronic urges all physicians to return explanted products and to notify Medtronic when a product is no longer in use, regardless of the reason for explant or removal from use. The procedures for returning products vary by geographic location.

Mailer kits with prepaid US postage are available for use within the United States to send CRTs, ICDs, IPGs, ICMs, and leads to Medtronic’s CRM Returned Product Analysis Lab. These mailers are sized to accommodate the devices and leads from a single patient or clinical event and are designed to meet US postal regulations for mailing biohazard materials.

If the product being returned is located outside the United States, please contact your local Medtronic representative for instructions.

Medtronic also requests the return of explanted products from non-clinical sources, such as funeral homes, and will assume responsibility for storage and disposal of the product once received.

Mailer kits can be obtained by contacting the Returned Product Lab. For information on how to contact the Lab, refer to the Contact Information page of this report.

We continually strive to improve this CRM Product Performance Report. In keeping with this philosophy, we ask for your suggestions on the content and format of this report, as well as any information you have regarding the performance of Medtronic products. For information on how to comment on this report, see the Contact Information page.

Overview of Survival Analysis

Medtronic uses the Cutler-Ederer actuarial life table method for devices, standard actuarial method for TPS and Kaplan-Meier for leads to estimate the length of time over which they will perform within performance limits established by Medtronic. This probability to perform within performance limits over time is called the survival probability.

Devices and leads are followed until an event occurs where the device or lead ceases to operate within performance limits. The length of time from implant to the event is recorded for individual devices and leads in the population sample. The population sample for CRT, ICD, and IPG devices is made up of patients whose devices are registered as implanted in the United States. For leads, the population sample is the patients enrolled in our multicenter, international prospective Product Surveillance Registry. For TPS, the population is the de-identified devices on the Medtronic CareLink™ network.

For CRTs, IPGs and ICDs, the events can be normal battery depletion or a device malfunction. For leads, the events are complications as defined in the study protocol. For TPS, the events are complications or malfunctions as defined in the methods for estimating.

The actuarial life table method allows Medtronic to account for devices and leads removed from service for reasons unrelated to performance and for device and leads still in service. Devices and leads removed for reasons unrelated to performance or are still in service are said to be suspended. Examples of devices and leads removed from service for reasons unrelated to performance include:

  • Removed to upgrade the device or lead
  • No longer in service due to the death of the patient for reasons unrelated to the device or leads
  • Implanted in patients who are lost to follow-up

For each suspension, the device or lead has performed within performance limits for a period of time, after which its performance is unknown.

Confidence Intervals

Since survival curves are based on a sample of the device and lead population, they are only estimates of survival. The larger the effective sample size, the more confident the estimate. A confidence interval can be calculated to assess the confidence in an estimate. In the Product Performance Report, Medtronic provides a 95% confidence interval. This can be interpreted as meaning that 95% of the time, the true survival of the device will fall somewhere in the interval.

Survival Curves in the Product Performance Report

Since the survival estimate can become very imprecise with small effective sample sizes, Medtronic truncates the survival curve when the effective sample size is less than 100 for CRTs, ICDs, and IPGs, and when the number entered is less than 50 for leads. The survival charts in the Product Performance Report show the effective sample size for each year interval where Medtronic has experience. When the effective sample size reaches 100 for CRTs, ICDs, and IPGs or when the number entered reaches 50 for leads, the next data point is added to the survival curve.

Although the report provides tabular data in one-year intervals, the device curves are actually computed and plotted using the Cutler-Ederer method and 1-month intervals (for CRT, ICD, and IPG devices), the TPS curves are actually computed and plotted using the standard actuarial method and 1-month intervals, and leads curves are computed and plotted using Kaplan-Meier, which uses individual survival times.

A number of references are available for additional information on survival analysis using the Cutler-Ederer life table method1 and for the Kaplan-Meier method.2

1Lee, Elisa T.(2003) Statistical Methods for Survival Data Analysis – 3rd Edition (Wiley Series in Probability and Statistics).

2Klein, John P., Moeschberger, Melvin L. Survival Analysis Techniques for Censored and Truncated Data, New York: Springer-Verlag New York, Inc., 1997. 1001052