Class 2 Device Recall St. Jude Medical

• Date Initiated by Firm: July 31, 2003
• Date Posted: October 24, 2003
• Recall Status: Terminated on March 26, 2004
• Recall Number: Z-0052-04
• Recall Event ID: 27045
• PMA Number: P880086
• Product Classification: Implantable Pacemaker Pulse-Generator - Product Code DXY
• Product: Pulse Generator
• Code Information: Integrity ADx DR Model 5360 & 5366 Identity ADx DR model 5286, 5380, 5386 &5480 Verity ADx DR 5256, 5356 & 5456
• Recalling Firm/ Manufacturer: St Jude Medical; 15900 Valley View Court; Sylmar CA 91342
• For Additional Information Contact: Nes Kusnierz; 818-362-6822
• Manufacturer Reason for Recall: Under certain circumstances, pacemaker has a potential to deliver a short coupled pacing interval of approx. 300 msec (200ppm). It is also possible that a patient may experience (up to max of 12) shorter than anticipated pacing intervals.
• FDA Determined Cause: Other
• Action: Sales Representatives will personally contact the physicians, explain the situation, leave a technical memo and a list of implanted patients for the doctor to follow-up with. The ''Dear Doctor'' letter to accompany the representatives is dated 7/31/2003. Instruments not implanted will be returned for reprocessing.
• Quantity in Commerce: 775
• Distribution: Nationwide and to four VA Medical Centers in IA and MO.
• 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 = DXY