Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.
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It was reported that the patient was in the icu due to their seizures.The patient had fallen, broke their ankle, and had to have ankle surgery.After the surgery, it was observed that the vns was constantly stimulating and causing asystole.The patient had undergone an ecg and it was confirmed that the during the vns stimulation, the patient would experience asystole.The hospital requested that the device be disabled; the patient is currently using their magnet to inhibit the stimulation.No other relevant information has been received to date.
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