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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The device was explanted and returned to undergo product analysis.While undergoing analysis, during system diagnostic testing an irregular waveform was discovered which is indicative of higher voltage being pulled, and therefore higher output current provided during system diagnostic tests.This was likely due to the faulty performance of the asic (a2).No other relevant information has been received to date.
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