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 a patient went in for a generator replacement surgery.When turning on the new generator, the patient experienced asystole.Per the physician's assessment, the cause of bradycardia is vns stimulation.The asystole occurred during the impedance measurement, which recovered when stimulation was off.During titration, again patient had asystole which recovered when stimulation was off.The patient did not have a prior history of cardiac events, pre-existing medical conditions, or family history of cardiac events.Intervention was not taken for the intraoperative arrhythmia.The generator is currently programmed on and arrhythmia has not reoccurred.No other relevant information has been received to date.
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