FDA-Device2024-01-31Class II
Model A710 Intellis Clinician Programmer Application, version 2.0.97
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.
Sold states
Germany
Affected count
1 tablet
Manufactured in
7000 Central Ave Ne, N/A, Minneapolis, MN, United States
Products
Model A710 Intellis Clinician Programmer Application, version 2.0.97
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0780-2024Don't want to check this manually?
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