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Medtronic Neuromodulation recalls Model A710 Intellis Clinician Programmer Application, version 2.0.97

Recalled January 31, 2024 · FDA recall Z-0780-2024 · Medtronic Neuromodulation

Hazard
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. · FDA Class II
Units
1 tablet
Sold at
Germany

Description

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.

Product
Model A710 Intellis Clinician Programmer Application, version 2.0.97
Manufacturer(s)
Medtronic Neuromodulation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Medtronic Neuromodulation recalls Model A710 Intellis Clinician Programmer Application, version 2.0.97 | RecallWatchUSA