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 after the conclusion of replacement surgery, high impedance was seen on the patient's device.Per the rep, the impedance were all within normal limits on the day of surgery at.X-rays were recommended as there is a possibility of incomplete pin insertion.Later, the surgeon had confirmed that surgery was scheduled to correct this high impedance.X-rays were provided in which no obvious cause for the high impedance could be identified.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.
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