Date Initiated by Firm | November 11, 2004 |
Date Posted | January 15, 2005 |
Recall Status1 |
Terminated 3 on March 08, 2005 |
Recall Number | Z-0396-05 |
Recall Event ID |
30494 |
PMA Number | P030017 |
Product Classification |
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief - Product Code LGW
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Product | Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System |
Code Information |
All Codes |
Recalling Firm/ Manufacturer |
Advanced Bionics Corporation 12740 San Fernando Rd Sylmar CA 91342-3728
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For Additional Information Contact | Kay Adair 661-362-1669 |
Manufacturer Reason for Recall | A burn injury was sustained by a patient that did not follow the directions for use and also slept while charging the unit. |
FDA Determined Cause 2 | Other |
Action | Firm has notified all consignees and thier clinicians to provide them with the labeling addenda. Patient notices were sent by FedEx or by US Mail and clinicians were faxed the notice. |
Quantity in Commerce | 237 patients are implanted. |
Distribution | Nationwide |
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 = LGW
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