WASHINGTON, D.C. — MEDTECH DIVE published an online report detailing the problems LivaNova experienced with its vagus nerve stimulation device implanted in patients suffering from severe depression or epilepsy, which necessitated a Class I recall by the U.S. Food and Drug Administration (FDA). Under FDA regulations, a Class I recall is the most urgent recall classification used by the agency. LivaNova’s recalled device, named SenTiva Generator System, failed to work correctly in fourteen patients. Four out of those fourteen patients required revision surgery to replace the failed medical device. LivaNova is unaware of any fatalities or injuries caused by device failure. The FDA said that revision surgery could be a risky procedure that could cause a host of debilitating or fatal side effects.
Approximately 2,900 patients in the U.S. wear LivaNova’s SenTiva Generator System implant. The implant stimulates the patient’s vagus nerve, which should prevent or reduce symptoms of depression or epileptic episodes, depending on the patient’s medical condition. LivaNova warns implant wearers to beware of device reset, loss of stimulation, or an increase in symptomology. The presence of any of those conditions indicates the patient could have a defective device. LivaNova asked patients experiencing adverse effects to contact their physician immediately for treatment, which might include revision surgery and device replacement.
LivaNova said that all device failures happened within the first two months from the start of the therapy. The company said that it has implemented steps to mitigate the reset problem and that the FDA continues to oversee its mitigation efforts.
LivaNova said revision surgery is rarely necessary. The device maker claims that physicians could set the instrument in “magnet mode,” so the patient could confirm the device works. The company suggested that doctors should monitor stimulation and conduct diagnostic testing at each office visit.
The recalled implant sits in the patient’s chest. The device sends signals to the patient’s brain via the vagus nerve in the patient’s neck. The FDA approved the use of this device in children as young as four-years-old.
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