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's generator was explanted on due to an unknown reason.During the surgery it was reported that there was injury to the vagal nerve, but the patient was stable upon removal.The lead remains implanted in the patient.The device data was evaluated for a malfunction and no malfunction was identified, the generator is operating as expected.No other relevant information has been received to date.
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