It was reported that after battery replacement (due to completely depleted battery), the new battery was showing low impedance upon interrogation.Visual examination of the lead resulted in fluid being found in the leads and a small hole in outer coating.The surgeon was able to extrude fluid from the leads via the hole.The surgeon elected to attach the new generator to the faulty lead, leave it the device off, and schedule patient for lead revision at another time.No additional known relevant surgical intervention has occurred to date.No other relevant information has been received to date.
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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.Medical device problem :a040507.
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