FDA recall Z-0612-2021

Medtronic Neuromodulation · Class II · device

Product

Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease, essential tremor, dystonia, obsessive-compulsive disorder, and epilepsy.

Reason for recall

A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device.

Distribution

US Nationwide distribution including in the states of Arizona, California, New Hampshire, Pennsylvania, Tennessee, Texas, Washington.

Key facts

Status
Terminated
Initiation date
2020-11-19
Report date
2020-12-23
Termination date
2023-04-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0612-2021