FDA-Device2015-05-27Class II
Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
Medtronic Neuromodulation
Hazard
Medtronic is providing Important information regarding extension handling during implant procedure after receiving reports of high impedances. This applies to extension Models 37085 and 37086 which can be used with the following implantable Neurostimulators: Activa¿ PC (Model 37601), Activa¿ RC (Model 37612), and the Activa¿ SC (Model 37603).
Sold states
worldwide
Affected count
86,851 (US 37,933 / OUS 48,918)
Manufactured in
7000 Central Ave Ne, N/A, Minneapolis, MN, United States
Products
Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1617-2015Don't want to check this manually?
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