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.
Check against the official notice below — it lists the full affected range.
Medtronic has recalled 12 Percept PC implantable neurostimulator devices used for deep brain stimulation therapy. The devices, distributed nationwide across seven states, are affected by a software problem in the A620 Patient Programmer application that prevents the programmer from connecting to the device. The specific serial numbers involved are NPI706941H, NPI707024H, NPI707000H, NPI706992H, NPI706963H, NPI706962H, NPI706987H, NPI706945H, NPI706952H, NPI706954H, NPI706955H, and NPI706957H.
The record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device.
Reason for recall: A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device. Distribution: US Nationwide distribution including in the states of Arizona, California, New Hampshire, Pennsylvania, Tennessee, Texas, Washington. Quantity: 12 devices Lot/code info: Model Number: B35200; GTIN: 00763000253363; Serial Numbers: NPI706941H, NPI707024H, NPI707000H, NPI706992H, NPI706963H, NPI706962H, NPI706987H, NPI706945H, NPI706952H, NPI706954H, NPI706955H, NPI706957H
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.