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 device was attempted to be removed, but the procedure resulted in bleeding and excessive scarring so the surgery was aborted.The surgeon identified the vagus higher up in the incision, and attempted to remove the lead from there, but as it was stuck and fibrosed there was a brisk hemorrhage.Per the physician, the fibrosis was believed to be caused by patient physiology as the lead had been placed for 12 years during which, the patient grew.The physician also indicated that the hemorrhage was due to the disturbance of the fibrosis.A suture was placed on the area to control the bleeding.No other relevant information has been received to date.
|