Recall Z-2657-2023 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Medtronic Neuromodulation
Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
| Date | Sep 29, 2023 (initiated Jul 17, 2020) |
| Status | Terminated |
| Reason | The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software resulting in the programmer having an inability to establish communication with the implanted neurostimulators. |
| Root cause | Software design |
| Action | Letters dated July 2020 and flagged as "URGENT: MEDICAL DEVICE CORRECTION RESTORE CLINICIAN PROGRAMMER APPLICATION SOFTWARE UPDATE Model A71100" were issued via USPS Priority First Class Mail on 7/17/2020. The letter provided an issue summary and informed the consignee the updated version of the A71100 application was now available for download and installation for resolving the issue. The consignee was to follow the instructions provided with the letter to update the application and if assistance was needed, contact information was provided for the Technical Services team support. Once |
| Quantity | 2,408 devices |
| Distribution | Worldwide distribution - US Nationwide (there was government and military distribution) and the countries of Australia and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.