Reported Dec 23, 2020 · Terminated
Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep…
Medtronic Neuromodulation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neuromodulation · 7000 Central Ave Ne · Minneapolis, MN · 55432-3568
Is this the product you have?
- Percept PC Implantable
- Neurostimulator (INS) - Product UsageThe 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
- Lot codes and dates
- Model NumberB35200
- GTIN00763000253363
- Serial Numbers
NPI706941HNPI707024HNPI707000HNPI706992HNPI706963HNPI706962HNPI706987HNPI706945HNPI706952HNPI706954HNPI706955HNPI706957H
- Amount recalled
- 12 devices
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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