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Recall Observatory FDA recall evidence

Device 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.

Z-0612-2021

November 19, 2020

Class II

Product summary

Firm
Medtronic Neuromodulation
Event
Event 86907
Status
Terminated
Classification
Class II
Quantity
12 devices
Official record key
device-enforcement:Z-0612-2021

Official wording

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

Code information: Model Number: B35200; GTIN: 00763000253363; Serial Numbers: NPI706941H, NPI707024H, NPI707000H, NPI706992H, NPI706963H, NPI706962H, NPI706987H, NPI706945H, NPI706952H, NPI706954H, NPI706955H, NPI706957H

Distribution pattern: US Nationwide distribution including in the states of Arizona, California, New Hampshire, Pennsylvania, Tennessee, Texas, Washington.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software anomaly