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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Additional information was received that the patient underwent surgery.During surgery, it was noted that the generator was tested using a test resistor and the diagnostics was within normal limits.The surgeon then removed the scar tissue that was built up around the lead where it would be inserted into the generator and reconnected them.Once re-connected, it was noted that the diagnostics was within normal limits multiple times.No other relevant information has been received to date.
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