Voluntary medical device correction (remedial action) was initiated by the manufacturer on 11/16/2018 via physician notification letter.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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Physician reported that he had a patient in the past that was probably affected by the m1000 increased impedance.A review of device history records for the generator showed that no unresolved non-conformances were found.Internal investigation identified that a change in the timing of the impedance test may result in higher impedances for model 1000 generator compared to those reported by model 103-106 generator.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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