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U.S. Department of Health and Human Services

Class 2 Device Recall Specify neurostimulation leads

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  Class 2 Device Recall Specify neurostimulation leads see related information
Date Initiated by Firm January 11, 2016
Create Date February 23, 2016
Recall Status1 Terminated 3 on January 20, 2017
Recall Number Z-0859-2016
Recall Event ID 73139
PMA Number P840001S096 P840001S126 
Product Classification Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
Product Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a neurostimulation system for treating chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.
Code Information All lot/serial numbers are affected for both Model numbers: 39565 and 39286
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis MN 55432-3568
For Additional Information Contact Medtronic Neuromodulation
800-707-0933
Manufacturer Reason
for Recall		 Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between permanent surgical implant and trialing/screening use.
FDA Determined
Cause 2		 Labeling design
Action Consignees were sent a Medtronic "Medical Device Correction" letter dated January 2016. The letter was addressed to Healthcare Professional. The letter described the problem and the product involved in the recall. Advised consignees to ensure their staff of the action that is being recommended. Requested consignees to complete and return the "Physician Confirmation Form". For additional information they can contact Medtronic Neuromodulation Technical services at 1-800-707-0933 weekends 7 am - 6 Pm Central time.
Quantity in Commerce 51,138 (44,006 US; 9,132 OUS)
Distribution Worldwide Distribution, including US 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 = MEDTRONIC NEUROMODULATION
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