Recall Z-1926-2016 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Medtronic Neuromodulation
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.
| Date | Jun 7, 2016 (initiated May 3, 2016) |
| Status | Terminated |
| Reason | 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 | Under Investigation by firm |
| Action | 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 1-800-70 |
| Quantity | 60,941 |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.