Recall Z-1691-2024 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Medtronic Neuromodulation
Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
| Date | Apr 26, 2024 (initiated Mar 28, 2024) |
| Status | Open, Classified |
| Reason | inability to reprogram one device |
| Root cause | Under Investigation by firm |
| Action | Medtronic issued an URGENT FIELD SAFETY NOTICE to its sole consignee on 03/28/2024 via via an in-person delivery of the customer letter by the Technical Services Representative. The notice explained the issue and risk of resetting the device. Also included were trouble shooting steps and a factory reset to be initiated by Medtronic upon the implanting physicians' authorization. |
| Quantity | 1 unit |
| Distribution | International distribution in the country of UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.