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 scheduled for a battery replacement.When it was interrogated, high impedance was seen.The battery was replaced, and once a new generator was connected to the lead, the impedance remained high.The electrode pin was cleaned and rinsed five times, yet the impedance remained high.The surgeon noted it would be very complicated to revise the electrode at that moment and insisted that the problem was with the generator.A backup generator was connected to the lead, and the impedance was still high.The initially intended replacement generator was implanted and turned off.No other relevant surgical intervention has occurred to date.No other relevant information has been received to date.
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