Recall – INS software anomaly results in failure to connect

Company: Medtronic Neuromodulation
Date of Enforcement Report: 12/23/2020
Class 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.

Recall Number: Z-0612-2021


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


Medtronic Neuromodulation on 11/19/2020. Voluntary:  Firm Initiated recall is ongoing.


12 devices


U.S. Nationwide

62304 Software Training Course – February 23-25, 2021

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