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Recall Observatory FDA recall evidence

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

November 12, 2020

Class II

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

    reason.no_named_rule · v1.0.0

    During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.