The patient's device was checked and was found to have low output current and the lead impedance value was within normal limits.It was also noted that only an interrogation could be performed but not a system diagnostics test.The patient also reported experiencing increased seizures.Device history records review for the m1000 generator performed.The generator passed final functional and quality specifications prior to release for distribution.Internal data from the generator was received and reviewed.Internal investigation into confirmed cases were unable to determine a definitive root cause of reed switch failures.The primary root cause is believed to be reed switches sticking in the closed position after extended exposure to magnetic fields.The investigation also identified residual magnetic properties of the generator battery to be a potential contributor; however, testing performed during the investigation found the effect to be highly variable with each magnetic field exposure and any closure of the reed switch impacted by this phenomenon would likely be reversed by subsequent swiping of the patient magnet.Thus, the most likely contributor of the identified complaints is considered to be mechanical sticking of the reed switch blades.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 "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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