FDA recall Z-0780-2024

Medtronic Neuromodulation · Class II · device

Product

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.

Distribution

Germany

Key facts

Status: Ongoing
Initiation date: 2023-12-19
Report date: 2024-01-31
Voluntary/Mandated: Voluntary: Firm initiated
Location: Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0780-2024