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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Lead Kit for Spinal Cord Stimulation

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  Class 2 Device Recall Medtronic Lead Kit for Spinal Cord Stimulation see related information
Date Initiated by Firm March 01, 2008
Date Posted September 16, 2008
Recall Status1 Terminated 3 on June 05, 2012
Recall Number Z-1912-2008
Recall Event ID 48070
PMA Number P840001S075 
Product Classification Spinal-cord stimulator implanted for pain relief - Product Code LGW
Product Medtronic 1x8 3777-xx, Low Impedance Lead Kit for Spinal Cord Stimulation (SCS), Contents of the inner package are STERILE. Method of sterilization: Ethylene Oxide, Rx Only,
Code Information Model 3777-75, Lot number V030733, Serial numbers V030733017, V030733018, V030733026.
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
800 53rd Ave NE
PO Box 1250
Minneapolis MN 55440-1250
For Additional Information Contact
763-514-5174
Manufacturer Reason
for Recall		 Medtronic Model 3777-75 Octad 1x8 Leads, Lot V030733 contain accessory stylets that are not the correct length.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Consignees were sent a Medtronic Letter dated March 2008. The letter described the product model / serial number and problem. It gave the option in assisting in returning the product for replacement or credit. A Medtronic Inter-Office Memo was also issued to "Affected Field Personnel" . The memo described the product /problem and the action required . Contact Medtronic Neuromodulation Quality at 651-367-0628 if you have questions.
Quantity in Commerce 3
Distribution NC, FL
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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