Recall Z-0780-2024— Medtronic Neuromodulation
Class II · Ongoing
Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2023-12-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Model A710 Intellis Clinician Programmer Application, version 2.0.97. 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..
- Recalling firm
- Medtronic Neuromodulation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-12-19
- Firm location
- Minneapolis, MN, United States
Product description
Model A710 Intellis Clinician Programmer Application, version 2.0.97
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.