FDA-Device2023-11-29Class II
Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
Medtronic Neuromodulation
Hazard
Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.
Sold states
International distribution to the countries of S. Korea and Turkey.
Affected count
26 units
Manufactured in
7000 Central Ave Ne, N/A, Minneapolis, MN, United States
Products
Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0354-2024Don't want to check this manually?
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