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.Health effect - impact code :f1001.
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It was reported that the patient was seen with high impedance and low output current.It was noted that x-rays were performed, and is now being referred for surgery.Patient was noted to have recently had a battery replacement and since then, experienced an increase in seizure frequency.The device settings was noted to be set lower than usual after the battery was replaced.Recently, the patient experienced an intense shock which resulted in the patient falling on the floor vomiting.Device was disabled.More information was received noting that the patient underwent surgery and after the surgeon removed, cleaned, and re-inserted the pin the device was within normal limits.No other relevant information has been received to date.
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