FDA-Device2020-12-23Class II
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.
Medtronic Neuromodulation
Hazard
A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device.
Sold states
US Nationwide distribution including in the states of Arizona, California, New Hampshire, Pennsylvania, Tennessee, Texas, Washington.
Affected count
12 devices
Manufactured in
7000 Central Ave Ne, N/A, Minneapolis, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0612-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief