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 high lead impedance.They had experienced multiple falls prior to this reading.Their generator was tested in the operating room with the test resistor, and impedance was normal, indicating it was a lead issue.The lead was replaced, and impedance was within normal limits with the new lead.X-rays were taken for the patient's high impedance, but could not be provided to livanova for review.The physician noted that the high impedance could be related to the patient's falls, but this could not be proven.The explanted lead has not been received by the manufacturer to date.No other relevant information has been received to date.
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