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