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 in january 2023, the patient had a revision surgery due to keloid scarring.It was later explanted due to this keloid and device extrusion.The family had difficulty controlling the patient's scratching of the site.The patient is noted to have a history of poor wound healing and malnutrition.Per the physician, it is speculated that this was the cause of the keloid scarring and extrusion.The explanted device was discarded and is not available for return to manufacturer.No other relevant information has been received to date.
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