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 patient¿s vns was permanently disabled due to pain, painful stimulation, an increase in seizures above pre-vns baseline levels, and increase in seizure intensity.The device was also suspected/alleged to be faulty.Device history records were reviewed.The device passed all functional and quality testing prior to distribution.No other relevant information has been received to date.
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