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