It was reported that during a follow-up after a generator replacement, the mother observed that the chest incision site was red and had dehiscence.Patient was noted to be sent to the emergency room for evaluation and was found that it was caused by a reaction with the sutures.Mother then observed the area was swollen, feeling hot, and was secreting.Patient was prescribed medication and underwent additional surgery in which the surgeon punctured the area to remove the seroma.The physician noted that the assessed cause of these events is due to the patient's reactions to suture thread.Device history records were reviewed for the device.The device passed all functional specifications and quality tests and was hp sterilized prior to distribution.Device evaluation will not be necessary as it will add no value to the investigation since the root cause is known no other relevant information has been received to date.
|
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.
|