Device product
VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
Z-0659-2016
Product summary
- Firm
- Cyberonics, Inc
- Event
- Event 72896
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,935 units
- Official record key
device-enforcement:Z-0659-2016
Official wording
Reason: Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Model 106 AspireSR Generator, resulting in a device reset condition where stimulation output is disabled.
Code information: All VNS Therapy AspireSR (Model 106) Generators; Device Identifier - (01)05425025750061
Distribution pattern: Worldwide Distribution -- United States, Austria, Belgium, Croatia, Czech Republic, Finland, France, Germany, Iceland, Italy, Netherlands, Norway, Poland, Slovakia, Spain, Sweden, Switzerland, United Kingdom, Cyprus, Israel, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, and United Arab Emirates.
Derived failure modes
-
Unknown
Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Model 106 AspireSR Generator, resulting in a device reset condition where stimulation output is disabled.