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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It was reported that the patient has been experiencing an increase in seizures daily seizures each lasting up to 30 minutes over the past 2 weeks and has not felt stimulation during this time.The patient's device was checked and all values were within normal limits and the patient reports after the device was interrogated, she started feeling the stimulation again, and her seizures got better.Additional information received noting that the cause of the increased seizure frequency and length is unknown but the patient reported not being able to feel stimulation and the increased started when she no longer felt stimulation.It was noted that the patient was having seizures every three months and then it increased to daily and then reduced again after interrogation.It is not clear if the every 3 month timeline was pre-vns baselines levels.The patient has been referred for a battery replacement.No known surgical intervention has occurred to date.No other relevant information has been received to date.
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