It was reported that the patient was seen to have an infection at the neck incision site.The infection is primarily located around the jugular and lead, and a little bit around the carotid.Patient was previously known to be a "picker" (known to manipulate the incision sites).A ct scan was performed, no notable findings resulted from this scan.Device history records were reviewed for the generator and lead.The generator and lead passed all specifications prior to distribution.The generator and lead were hp sterilized.Device evaluation is not necessary because the reported event has been determined to be related to the implant procedure no other relevant information has been received to date.
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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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