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.Device evaluated by mfr? code 81 - device evaluation is not necessary because the reported event has been determined to be related to the implant procedure.
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It was reported by the patient's guardian, following a surgery consult, that during the patient's previous replacement surgery, the patient's incision was irritated and took a while to heal.The guardian observed that the site/scar was wide and suspected that perhaps the previous surgeon sutured the skin too tight.The guardian was unsure if the scarring would change anything for the patient's upcoming replacement surgery.No known relevant surgical intervention has occurred to date.
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