Recall Z-0780-2024 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Medtronic Neuromodulation
Model A710 Intellis Clinician Programmer Application, version 2.0.97
| Date | Jan 22, 2024 (initiated Dec 19, 2023) |
| Status | Open, Classified |
| Reason | Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability for the clinician to adjust stimulation parameters. In the event of this issue, the patient may receive inadequate or excessive therapy and experience non-optimal pain relief. |
| Root cause | Under Investigation by firm |
| Action | OUS communication to a single German consignee will be initiated via regionally approved methods beginning 19-Dec-2023. A field service technician will go to the site and reset the INS to resolve the issue. |
| Quantity | 1 tablet |
| Distribution | Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.