Model A710 Intellis Clinician Programmer Application, version 2.0.97
This recall is currently active, issued January 22, 2024. It was issued by Medtronic Neuromodulation.
- Company
- Medtronic Neuromodulation
- Recall Initiated
- December 19, 2023
- Posted
- January 22, 2024
- Recall Number
- Z-0780-2024
- Quantity
- 1 tablet
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Germany
Lot / Code Info
UDI/DI 00763000520076, S/N: NPL1000519
Root Cause
Under Investigation by firm
Action Taken
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.