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 had suffered a grandmal seizure, which ultimately resulted the patient being hospitalized.The patient then suffered a heart attack and they were defibrillated as a result.Their device has not been interrogated after this defibrillation (as recommended in labelling).The patient does not currently have a neurologist, nor is the local rep aware of this events or any physicians that could provide an assessment on the cause of the events.No other relevant information has been received to date.
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