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.
This recall has been terminated (originally issued January 11, 2016).
- Company
- Medtronic Neuromodulation
- Recall Initiated
- January 11, 2016
- Terminated
- January 20, 2017
- Recall Number
- Z-0859-2016
- Quantity
- 51,138 (44,006 US; 9,132 OUS)
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution, including US Nationwide.
Lot / Code Info
All lot/serial numbers are affected for both Model numbers: 39565 and 39286
Root Cause
Labeling design
Action Taken
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.