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 from the physician noting that the lead malfunction was high impedance/lead fracture issue.It was noted that during the procedure the lead was disconnected from the generator, and when plugged back in, impedance remained high.It was then concluded that there was a lead fracture.Device diagnostics are noted to be within normal limits after lead revision.No other relevant information has been received to date.
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