LivaNova USA, Inc. is recalling approximately 8,307 SenTiva and SenTiva DUO Vagus Nerve Stimulation (VNS) Therapy generators because an internal component issue may cause the device to stop delivering electrical therapy signals to the patient. These implanted pulse generators are used to treat medical conditions by stimulating the vagus nerve, and any interruption in this process can impact the patient's treatment plan. Consumers with these implanted devices should not attempt to adjust them themselves but should immediately contact their healthcare provider or the manufacturer to discuss management and next steps.
The internal defect causes the implanted pulse generator to stop functioning, which results in the patient no longer receiving the intended vagus nerve stimulation. This loss of therapy can lead to a recurrence or worsening of the symptoms for which the device was originally prescribed, potentially requiring surgical intervention to replace the failed unit.
Healthcare provider consultation
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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