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U.S. Department of Health and Human Services

Class 1 Device Recall Medtronic Sprint Fidelis Lead

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  Class 1 Device Recall Medtronic Sprint Fidelis Lead see related information
Date Initiated by Firm October 15, 2007
Date Posted October 25, 2007
Recall Status1 Terminated 3 on June 21, 2011
Recall Number Z-0068-2008
Recall Event ID 45403
PMA Number P920015 
Product Classification implantable defibrillator lead - Product Code LWS
Product Medtronic Sprint Fidelis 6931 Steroid eluting, tripolar, screw-in, ventricular lead with right ventricular (RV) defibrillation coil electrode. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies. Medtronic World Headquarters, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.
Code Information all codes
Recalling Firm/
Medtronic Inc. Cardiac Rhythm Managment
7000 Central Ave Ne
Minneapolis MN 55432-3568
For Additional Information Contact Medtronic Patient Services
800-5515544 Ext. 41835
Manufacturer Reason
for Recall
Medtronic Cardiac Rhythm Disease Management has voluntarily suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads because of the potential for lead fractures. In addition, the company recommends against new implants of the leads (Sprint Fidelis Models: 6930, 6931, 6948, 6949). Medtronic, its Independent Physician Quality Panel, and Bruce Lindsay, M.D., Professor of
FDA Determined
Cause 2
Device Design
Action A press release was issued by Medtronic on 10/15/2007. An FDA Statement was also issued on 10/15/2007. An Urgent Medical Device Information letter, dated 10/15/2007, was sent to physicians. The letter states that Medtronic has suspended distribution of the leads, the leads should no longer be implanted and unused leads should be returned to Medtronic. This letter describes background information, performance and recommendations. Medtronic believes it is inappropriate to prophylactically remove Sprint Fidelis leads except in unusual individual patient circumstances. An Important Patient Information letter was addressed to Medtronic Heart Device Patients. Both letters can be found on Medtronic's website at www.medtronic.com/fidelis. Return of product will be achieved with the assistance of Medtronic Representatives.
Quantity in Commerce 235,000 for all models
Distribution Worldwide, including USA, Puerto Rico, Guam, and Northern Mariana Islands.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LWS and Original Applicant = MEDTRONIC Inc.