Date Initiated by Firm | July 31, 2003 |
Date Posted | October 24, 2003 |
Recall Status1 |
Terminated 3 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
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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
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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 2 | 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 |
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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.
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PMA Database | PMAs with Product Code = DXY
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