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 occur early in the life of a device; all currently confirmed reported device resets due to this issue have occurred within the first 60 days of implant based on patient and physician voluntary reporting.

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 are believed to be at minimal risk for this issue. To date, one (1) device disablement (which occurred approximately 6 months post-implantation) was reported in the more than 4,840 post-screen devices already implanted, of which more than 4,800 are at least 60 days post-implant. The investigation based on the available information was inconclusive on the root cause for the device disablement. No additional disablements on post-screen devices have been reported in the 6+ months since the event occurred.

In comparison, out of 1,713 known implanted devices within the scope of the recall (pre-screen), there have been 18 reported occurrences, all within 60 days of implant.

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 work closely with the FDA and to communicate with clinicians and patients implanted with potentially affected devices.

Enter your Model 1000 serial number to identify whether your device was distributed prior to implementation of the error screen.

IS MY DEVICE AFFECTED BY THIS RECALL?

Model 1000




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 Clinicaltechnicalservices@livanova.com.