FDA-Device2022-01-05Class II
Model B35200 - Percept PC BrainSense Implantable Neurostimulator
Medtronic Neuromodulation
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.
Sold states
Worldwide distribution - US Nationwide and Puerto Rico. The countries of Australia, Canada, Austria, Belgium, Canary Islands, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom, India, Japan, Korea, Republic Of, Argentina, Brazil, Colombia, Thailand, and Hong Kong.
Affected count
10,006 units
Manufactured in
7000 Central Ave Ne, Minneapolis, MN, United States
Products
Model B35200 - Percept PC BrainSense Implantable Neurostimulator
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0418-2022Don't want to check this manually?
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