Company: Medtronic Neuromodulation
Date of Enforcement Report: 12/23/2020
Class II
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.
Recall Number: Z-0612-2021
REASON
A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device.
RECALLING FIRM/MANUFACTURER
Medtronic Neuromodulation on 11/19/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
12 devices
DISTRIBUTION
U.S. Nationwide