Device product
Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106
Z-0280-2016
Product summary
- Firm
- Cyberonics, Inc
- Event
- Event 72385
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27 units
- Official record key
device-enforcement:Z-0280-2016
Official wording
Reason: Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit potential for decreased battery longevity.
Code information: Serial Numbers: 37719, 37899, 38123, 38414, 38428, 39385, 39531, 39607, 39801, 39821, 40037, 40048, 40249, 40251, 40271, 40354, 40428, 40488, 40526, 40603, 40751, 41000, 41109, 41152, 41805, 42022, 42780
Distribution pattern: US Distribution to the states of : OR, NY, GA, PA, CA, NC, KS, FL, KY, MI, TX, IL, OH, IN, UT, CO and WV.
Derived failure modes
-
Unknown
Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit potential for decreased battery longevity.