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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
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
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
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
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 = LGW and Original Applicant = Boston Scientific Corp.
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