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.
|
It was reported that the patient was currently admitted to the hospital due to an increase in seizures, new absence seizures, and a decline in function.Update was received that the patient had a generator replacement.Per the physician, the increase in seizures are due to low battery and external factors; the new absence seizures are due to low battery; and was unsure on the patient's seizure levels.The explanted device has not been received to date.No other relevant information has been received to date.
|