March 13, 2009
Medtronic is committed to keeping you informed about Sprint Fidelis lead performance and our ongoing vigilance efforts. To that end, we are providing the following summary of our most recent review of performance data and Medical Device Reports (MDR or MedWatch reports) with Medtronic’s Independent Physician Quality Panel, and the Panel’s updated patient management recommendations.
Lead Performance Update
Since the October 15, 2007 communication about the Sprint Fidelis family of leads, Medtronic and the Independent Physician Quality Panel have continued to analyze performance data from the Medtronic System Longevity Study (SLS) and the Medtronic CareLink® Network, as well as recent third party data. Table 1 below shows lead survival data for Sprint Fidelis from the SLS, the Medtronic CareLink Network and from third party reports at 30 to 45 months from implant recently reviewed by the Panel.
|Data Source||Sample Size (Leads)||30 Months||36 Months||45 Months|
In addition, there is a recent publication by Farwell, et al., (HeartRhythm, 2008; 5:1375- 1379) that is a subset of Krahn et al.
Review of Medical Device Reports
Approximately 268,000 Fidelis leads have been implanted worldwide. The FDA’s MAUDE database currently has 107 Medical Device Reports (MDRs) that include allegations that the Fidelis lead may have caused or contributed to a patient death. Most of these MDRs were not initiated by medical professionals; the majority were initiated by family members or attorneys with minimal supporting data. Medtronic’s Independent Physician Quality Panel has reviewed 89 of the 107 reports. It is not possible to determine cause of death with certainty.
The Panel has identified 13 patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor. The Panel noted that four of the 13 deaths were associated with lead extraction, highlighting the risks associated with that procedure. With the exception of the appearance of deaths associated with lead extraction, no new or unexpected trends have been observed.
Patient Management Recommendations
In consultation with the Independent Physician Quality Panel, our patient management recommendations are as follows:
Keeping Physicians Informed
To keep you informed, Medtronic continues to provide two ways to access regularly updated Sprint Fidelis® lead performance data. The Product Performance Report (PPR) contains SLS performance data for the Sprint Fidelis lead and other Medtronic leads and devices. The PPR is updated and published every six months with both current and past reports available at www.CRDMPPR.medtronic.com. Medtronic continues to post quarterly Sprint Fidelis lead performance updates from both SLS and Medtronic CareLink® online at www.medtronic.com/fidelis.
Medtronic continues to be committed to answering your questions and keeping you informed. If you have any questions or concerns, please contact your Medtronic Representative or Medtronic Technical Services at 1-800-723-4636 (US).
Vice President, Quality and Regulatory
Medtronic Cardiac Rhythm Disease Management