Recall Z-0905-06 ยท GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Medtronic Inc, Neurological & Spinal Division
Medtronic Model 37711 Restore Neurostimulator. The Restore Neurostimulator is an implanted, rechargeable neurostimulator which provides pain management therapy.
| Date | May 25, 2006 (initiated Nov 22, 2005) |
| Status | Terminated |
| Reason | A limited number of Model 37711 Restore Neurostimulators have an incorrect internal memory parameter that causes the device to indicate it is fully recharged when it may only be 80% to 90% recharged. This anomaly does not affect patient safety. This anomoly can be corrected by reprogramming the Restore Neurostimulator using specific software. |
| Root cause | Other |
| Action | A 'Customer Communication' letter was sent to Medtronic field personnel to hand-carry into the affected accounts; customer contact began on 11/22/2005. The letter explains the patients implanted with these devices likely will only be able to recharge their neurostimulator to about 80-90% of a full charge. This anomaly does not affect device safety or effectiveness but Medtronic will re-program them upon request for customer satisfaction. The letter will be followed by scheduled on-site visit to reset the internal memory parameter of the neurostimulator. |
| Quantity | 101 devices affected |
| Distribution | Nationwide (AZ, CA, FL, ID, IL, IN, KS, KY, MA, MD, MI, MO, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, and WI). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.