—#70789

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,

FDA product code: LGW — Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P840001S075
Affected lot / code info: Model 3777-75, Lot number V030733, Serial numbers V030733017, V030733018, V030733026.

Why it was recalled

Medtronic Model 3777-75 Octad 1x8 Leads, Lot V030733 contain accessory stylets that are not the correct length.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

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.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 800 53rd Ave NE PO Box 1250, Minneapolis, Minnesota 55440-1250

Distribution

Distribution pattern: NC, FL

Timeline

Recall initiated: 2008-03-01
Posted by FDA: 2008-09-16
Terminated: 2012-06-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #70789. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.