Device product
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.
Z-0535-2021
Product summary
- Firm
- LivaNova USA Inc
- Event
- Event 86776
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 generators
- Official record key
device-enforcement:Z-0535-2021
Official wording
Reason: During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.
Code information: Model Number - Model 1000-D Serial Numbers: 311298 310443 310068 310353 310531 310351 310380 310348
Distribution pattern: International distribution in the countries of Austria and United Kingdom.
Derived failure modes
-
Unknown
During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.