FDA-Device2024-10-30Class II
Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
Medtronic Neuromodulation
Hazard
A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an "Invalid Device" message will appear.
Sold states
International distribution to the countries of Germany, UK, and Israel.
Affected count
39 units
Manufactured in
7000 Central Ave Ne, N/A, Minneapolis, MN, United States
Products
Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0206-2025Don't want to check this manually?
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