MEDICAL DEVICE RECALL AND CORRECTION:
Reset and Device Disablement

Model 1000 SenTiva®
VNS Therapy® Generators

LivaNova has notified physicians starting on 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 reported device resets have occurred within the first 60 days of implant based on patient and physician voluntary reporting.

LivaNova is currently distributing Model 1000 devices that have passed a LivaNova internal error screen. The error screen is intended to detect devices susceptible to unintended device disablement. To date, no erroneous resets or device disablements have been reported in the more than 2,000 post-screen devices already implanted, of which more than 1,300 are 60 days post-implant. In comparison, out of 1,687 devices within the scope of the recall (pre-screen), there have been 15 reported occurrences, all within 60 days of implant.

FDA has 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.

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