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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Internal data from the generator was received and reviewed.The patient was then seen again in clinic and it was found that their battery had rebounded to 75-100% the battery rebound event was confirmed to be related to a known event cause by the impedance behaviors in the beginning of the battery's life.Internal investigation identified that in some cases, pulse generators reach the 25% battery indicator earlier than expected, and later rebound to 75-100% without any significant programming changes.This behavior was determined to be due to an increased duration of high battery impedance during generator battery beginning-of-life.There is no evidence of a device malfunction.
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