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U.S. Department of Health and Human Services

Class 2 Device Recall The Precision Spinal Cord Stimulator System

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  Class 2 Device Recall The Precision Spinal Cord Stimulator System see related information
Date Initiated by Firm April 22, 2008
Date Posted April 19, 2012
Recall Status1 Terminated 3 on April 19, 2012
Recall Number Z-1441-2012
Recall Event ID 49059
PMA Number P030017 
Product Classification Stimulator, spinal-cord, totally implanted - Product Code LGW
Product OMG (Observational Mechanical Gateway) Connector - A Model Number SC-9305
The Precision Spinal Cord Stimulator System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with following: failed back surgery syndrome, intractable low back pain and leg pain. The Precision System includes an implantable l6-output, multi-channel stimulator (lPO - Implantable Pulse Generator) with a rechargeable battery power source. The lPG, commonly implanted in the abdomen or buttock area, can be configured to accept one or two leads. The leads are implanted in the epidural space, adjacent to the spinal column. The stimulation delivered at the distal end of the lead is intended to mask the pain signals.
Code Information Model Number: SC-9305, Lot Number 170338
Recalling Firm/
Manufacturer		 Advanced Bionics Corporation
12740 San Fernando Rd
Bldgs. 1 & 3
Sylmar CA 91342
Manufacturer Reason
for Recall		 The recall was initiated because there is a possibility that the OMG Connector-A is incorrectly packaged with an OMG Connector-M Instruction manual.
FDA Determined
Cause 2		 Labeling mix-ups
Action Algotec Limited initiated a Field Safety Notice Urgent Medical Device Correction letter dated April 22, 2008, with Boston Scientific forwarding a recall letter to one customer who received the recalled product. The letter instructed the consignee to replace the previously packaged manual with the OMG Connector-A manual that was supplied with the notification. The replacement of the manuals is to be confirmed via the Verification form. Customers were instructed to complete and fax the Verification Form to their local Boston Scientific Customer Service to Fax 00 44 1442 411732 by 06 May 2008. For questions regarding this recall call 661-949-4481.
Quantity in Commerce 6 Units
Distribution Worldwide Distribution including Great Britian
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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