LivaNova USA, Inc. has recalled 81,654 SenTiva and SenTiva Duo Vagus Nerve Stimulation (VNS) Therapy Generators. These implanted devices may stop delivering stimulation because an internal component can become stuck in a closed position. If the device fails, patients may experience a return of seizure frequency or depressive symptoms and will likely require surgery to replace the failed generator.
A mechanical component inside the device can get stuck, preventing the delivery of electrical therapy to the nerve. This loss of stimulation can lead to a sudden return of seizures or depression symptoms and requires an additional surgical procedure to replace the non-functioning implant.
Part of the VNS Therapy System used for Vagus Nerve Stimulation (VNS).
Part of the VNS Therapy System used for Vagus Nerve Stimulation (VNS).
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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