—#143156

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.

FDA product code: LGW — Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P840001S096, P840001S126
Affected lot / code info: All lot/serial numbers are affected for both Model numbers: 39565 and 39286

Why it was recalled

Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between permanent surgical implant and trialing/screening use.

Root cause (FDA determination)

Labeling design

Action the firm took

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.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 7000 Central Ave Ne, Minneapolis, Minnesota 55432-3568

Distribution

Distribution pattern: Worldwide Distribution, including US Nationwide.

Timeline

Recall initiated: 2016-01-11
Terminated: 2017-01-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #143156. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.