Recalls / —
—#146106
Product
Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators. Used to treat 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
- P840001
- Affected lot / code info
- All lot/serial numbers are affected for both Model numbers 37714 and 97714.
Why it was recalled
Loss of therapy during recharging of device. Reportedly, a charging session was terminated prior to obtaining recharge threshold voltage of 3.615, which triggered rapid battery depletion state. As a result, the device depleted to 1.925 volts in one to two days rather than the typical 30 days. Insufficient coupling between recharger and device during recharge session was found to be key factor.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
Consignees were sent on 5/3/2016 a Medtronic "Urgent Medical Device Safety notification" letter dated May 2016. The letter was addressed to "Healthcare Professional". The letter described the problem and the product involved in the recall. The letter listed the recommendation to patients to follow current recharge instructions, paying particular attention to Charging Efficiency and Battery Charge Level indicators on the recharger. Consignees were also requested to complete and return the "Physician Reply Form:. For questions contact Medtronic Neuromodulation Technical services at 1-800-707-0933 weekdays 7 am - 6 pm CST.
Recalling firm
- Firm
- Medtronic Neuromodulation
- Address
- 7000 Central Ave, Minneapolis, Minnesota 55421-1241
Distribution
- Distribution pattern
- Worldwide Distribution
Timeline
- Recall initiated
- 2016-05-03
- Posted by FDA
- 2016-06-07
- Terminated
- 2017-08-04
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #146106. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.