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.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.
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It was reported that the patient underwent explant surgery due to scratching her incision site which led to her chest wound opening and exposing the generator.Due to risk of infection the generator was removed and chest pocket was cleaned out.No signs of infection observed but, the surgeon just wanted to take precautionary measures.Device history record was reviewed for the generator.The generator was confirmed to be hp sterilized prior to distribution, and no unresolved nonconformances were found prior to distribution.No other relevant information has been received to date.
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