Device product
Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106
Z-0645-2016
Product summary
- Firm
- Cyberonics, Inc
- Event
- Event 72698
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29 units
- Official record key
device-enforcement:Z-0645-2016
Official wording
Reason: Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit the potential for decreased battery longevity.
Code information: Serial numbers 36602, 37019, 39097, 40311, 40465
Distribution pattern: US Distributions to the states of : IL, NC, KS, and TX., and Internationally to the country of: United Kingdom.
Derived failure modes
-
Unknown
Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit the potential for decreased battery longevity.