medical Class II Updated 2020-12-23

Medtronic Neuromodulation recalls Percept PC Implantable Neurostimulator (INS) - Product Usage

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model Number: B35200; GTIN: 00763000253363; Serial Numbers: NPI706941H, NPI707024H, NPI707000H, NPI706992H, NPI706963H, NPI706962H, NPI706987H, NPI706945H, NPI706952H, NPI706954H, NPI706955H, NPI706957H
View official government recall

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