It was reported that when the device was checked impedance was ok.Mother also reports that since the patient fell at school he has continued to have an increase in seizures.She states that the pt.Has had seizures almost every day, with 3 yesterday, where sao2 dropped to 70% and pt.Had bradypnea with snoring sounds.No additional 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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