It was reported that the patient underwent a full device explant due to the patient's body rejected the device.It was also reported to have been re-implanted later on the right side with no problems.Device history records were reviewed.The device passed all functional specifications and quality tests and were sterilized prior to distribution.Per the physician, the believed cause of the rejection is due to patient physiology, and the explant was to preclude serious injury because the patient's body caused the device to extrude.No other relevant information has been received to date.
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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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