H3.Device evaluated by mfr? code 81 - device evaluation is not necessary because the reported event has been determined as not related to the functionality or delivery of therapy of the device 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 the patient's chest wound has opened up suspected to be due to an infection of the incision site.The patient was scheduled to have an explant procedure of the device to clean out the wound.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 wound opening up and infection is unknown.The explant was confirmed to have occurred on the planned date, but the explanted vns is unable to be returned.No other relevant information has been received to date.
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