Introduction to Product Performance eSource

This PPeSource website 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, and implantable pacing and defibrillation leads.

Survival Estimates
Medtronic Cardiac Rhythm Disease Management (CRDM) uses both returned product analysis and multicenter clinical studies to monitor performance.

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 US registered devices and returned product analysis. This approach is suitable for CRT, ICD and IPG devices 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.

Therefore, survival estimates for leads are based on clinical observations recorded via Medtronic CRDM’s Product Surveillance Registry. This multicenter clinical study started in 1983 and today includes more than 80 centers worldwide following more than 15,000 active leads.  The 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.

The actuarial life table method is applied to the data collected for CRT, ICD, and IPG devices and leads to provide the survival estimates included in this report. A general introduction to understanding this method of survival analysis is given here.

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

ICD Charge Times
Since May 2000, Medtronic has provided important information on charge time performance of ICDs. The information 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 System Longevity Study.

Advisory Summaries
PPeSource includes summaries of all advisories applicable to the performance of the products included in PPeSource. An advisory is added 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 maintained until Medtronic estimates no affected product remains in active service.

Performance Notes
Medtronic has developed a number of Performance Notes to provide additional product performance information relevant to follow-up practice and patient management.

 Serial Number Lookup Tool

The "Search for Information by Serial Number" tool provides a way to locate information specific to an indivual serial number. To obtain accurate results, the serial number must be entered accurately. This tool provides results only for current CRDM implantable IPG, ICD and CRT devices and leads. While Product Performance eSource has information on hundreds of Medtronic CRDM 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 Advisories and Performance Notes, 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, and leads to Medtronic’s CRDM 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 Contact Us.

We continually strive to improve this CRDM 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 Contact Us.

Applicable Standards

This website has been prepared in accordance with International Standard ISO 5841- 2:2000(E), and the  2009 AdvaMed document “Industry Guidance for Uniform Reporting of Clinical Performance of Cardiac Rhythm Management Pulse Generators and Leads”.

www.medtronic.com/productperformance 301050