Model A710 Intellis Clinician Programmer Application, version 2.0.97
FDA device recall Z-0780-2024 · posted 2024-01-22 · Open, Classified
Recall details
- Recalling firm
- Medtronic Neuromodulation
- 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.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- LGW
- Quantity affected
- 1 tablet
- Distribution
- Germany
- Date initiated
- 2023-12-19
- Date posted
- 2024-01-22
- Location
- Minneapolis, MN
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