Recall Z-0860-2021 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Medtronic Neuromodulation
Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by clinicians in the programming of the following Medtronic neurostimulators (external and implantable) for pain therapy.
| Date | Nov 12, 2020 |
| Status | Open, Classified |
| Reason | A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device. |
| Root cause | Software design (manufacturing process) |
| Action | Medtronic notified the first consignee by letter on 11/12/2020 with a confirmation of their complaint and request to perform a correction to the device which put the device in a factory-reset state and restore functionality to allow programming and continued therapy. On 17 Dec 2020, Medtronic will begin issuing an Urgent Medical Device Correction notification to physicians regarding this validation error and providing instructions on the impact and appropriate mitigating actions if this issue presents. |
| Quantity | 7960 downloads |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Canada, Latin America, Asia Pacific, Japan, China, and European regions. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.