FDAOctober 19, 2021device
Model B35200 - Percept PC BrainSense Implantable Neurostimulator
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure performed by a cardiologist to correct an abnormal heartbeat. Medtronic has determined that the cardioversion may damage the circuit electronics in the Percept PC stimulator, thereby, causing the Percept PC stimulator to become non-responsive.
What to do
FDA enforcement status: Ongoing
Brands named
medtronic neuromodulationmedtronic
UPCs
00763000253363
Recall history
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