Medtronic Sprint Quattro Secure S, model 6935. Steroid eluting, tripolar, screw-in, ventricular lead with RV defibrillation coil electrode. Contents Sterile. Manufactured in: Villalba, Puerto Rico, USA. Medtronic, Inc., Minneapolis, MN 55432 U.S.A.
Hazard
Over--retraction of the helix during initial implant or subsequent repositioning may result in the inability to extend the helix. This does not impact acute or chronic performance of successfully implanted leads.
What You Should Do
Remedy
Medtronic issued an Important Medical Device Correction letter, dated October 2010, to doctors. The letter contains a Performance Note. The letter describes the issue and the performance note provides information on how to mitigate the issue through replacement with a new lead. Customers can contact Medtronic Technical Services at 800 723-4636
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Products
Medtronic Sprint Quattro Secure S, model 6935. Steroid eluting, tripolar, screw-in, ventricular lead with RV defibrillation coil electrode. Contents Sterile. Manufactured in: Villalba, Puerto Rico
- Brand
- Medtronic Inc. Cardiac Rhythm Disease Managment
- UPC
- all devices are affected, however, it is an issue that can present itself only at the time of the surgical procedure (acute issue) and it doesn't affect teh chronic performance of a successfully implanted lead.
Units Affected
154,000 total