During a periodic programming history database review, high lead impedance was observed upon performing a system diagnostics.The impedance has been within normal limits ever since.Device history record review for the generator was performed.The generator passed final functional and quality specifications prior to release for distribution.Internal investigation identified that a change in the timing of the impedance test may result in higher impedances for model 1000 generators compared to those reported by model 103-106 generators.As indicated in the physician's manual, high lead impedance (5300 ohms), in the absence of other device related complications, is not an indication of a lead or generator malfunction.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 "efects 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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