—#184809

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.

FDA product code: MHY — Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Device class: Class 3
Medical specialty: Unknown
Affected lot / code info: Model Number: B35200; GTIN: 00763000253363; Serial Numbers: NPI706941H, NPI707024H, NPI707000H, NPI706992H, NPI706963H, NPI706962H, NPI706987H, NPI706945H, NPI706952H, NPI706954H, NPI706955H, NPI706957H

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

Beginning November 19, 2020 accounts impacted by this issue were verbally notified to quarantine affected product. Beginning November 25, 2020 a recall notification letter and retrieval instructions titled "URGENT: MEDICAL DEVICE RECALL A620 Patient Programmer issue with specific Percept" PC Neurostimulators" was hand delivered to impacted accounts by Medtronic Representatives.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 7000 Central Ave Ne, Minneapolis, Minnesota 55432-3568

Distribution

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

Timeline

Recall initiated: 2020-11-19
Terminated: 2023-04-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184809. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.