FDA-Device2020-12-16Class II
VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode.
LivaNova USA Inc
Hazard
During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.
Sold states
International distribution in the countries of Austria and United Kingdom.
Affected count
8 generators
Manufactured in
100 Cyberonics Blvd, N/A, Houston, TX, United States
Products
VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0535-2021Don't want to check this manually?
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