Class 1 Device Recall Medtronic Sprint Fidelis Lead

• Date Initiated by Firm: October 15, 2007
• Date Posted: October 25, 2007
• Recall Status: Terminated on June 21, 2011
• Recall Number: Z-0070-2008
• Recall Event ID: 45403
• PMA Number: P920015
• Product Classification: implantable defibrillator lead - Product Code LWS
• Product: Medtronic Sprint Fidelis 6949 Steroid eluting, quadripolar, screw-in, ventricular lead with right ventricular (RV) / Superior Vena Cava (SVC) defibrillation coil electrodes. 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/ Manufacturer: 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: 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