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. Of 1,714 known implanted devices, 20 confirmed device resets have been reported due to this issue. Eighteen (18) reported resets occurred within the first 60 days of implant. The remaining two (2) devices experienced initial resets more than 60 days after implant (at 7 and 15 months post-implantation, respectively).

In August 2019, LivaNova began distributing Model 1000 devices that had passed a LivaNova internal error screen. The er