MEDICAL DEVICE RECALL AND CORRECTION:
Reset and Device Disablement
Model 1000 SenTiva™
VNS Therapy™ Generators
LivaNova notified physicians starting August 22, 2019 that unintended device disablement resulting from a device reset may occur in some Model 1000 generators with SN ≥ 100,000 due to a component supplied by an outside company. Our testing has observed that these erroneous resets most commonly occur early in the life of a device. From the known implanted devices that were distributed prior to the internal screening and updated firmware, there is an estimated failure rate of 1.11% for a reset occurring within the first 60 days of implant. Although there have been a few known cases in which a device reset occurred > 60 days after implant, this is not likely with an estimated failure rate of 0.21% per device-year.
In August 2019, LivaNova began distributing Model 1000 devices that had passed a LivaNova internal error screen. The error screen was intended to detect devices susceptible to unintended device disablement. Those passing the error screen have demonstrated significantly lower failure rates for this issue with an estimated occurrence rate of 0.02% per device-year.
FDA classified this as a Class I recall due to the risks associated with a secondary surgery to replace the Model 1000 generator if it experiences a reset. No deaths have been reported to LivaNova as a result of this device disablement. A non-invasive device update to correct the issue is now available for affected devices that experience a reset.
The Company takes this very seriously as patient safety is our top priority. LivaNova is committed to quality and integrity, which is why upon identifying this issue, LivaNova initiated a field action (recall) and took proactive steps in notifying the medical community and FDA of the potential device reset and disablement. We continue to take any reports of device resets seriously and continue to communicate with clinicians and patients implanted with potentially affected devices.
For any questions related to this recall, or for Clinical / Technical Support for VNS Therapy, contact LivaNova’s Customer Quality Team at 1-866-882-8804 or via email at email@example.com