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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 Recall
Medtronic Lead Kit for Spinal Cord Stimulation
see related information
Date Posted September 16, 2008
Recall Status1 Open
Recall Number Z-1912-2008
Recall Event ID 48070
Premarket Approval
PMA Number
P840001/S075
Product Classification Stimulator, Spinal-Cord, Totally 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, Minnesota 55440-1250
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LGW and Applicant = MEDTRONIC VASCULAR
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