Device 3 of 4: reference manufacturer report: 3006705815-2018-00723, 3006705815-2018-00724, 1627487-2018-03416.It was reported the patient was seen in the doctor's office with a suspected infection at the midline incision which had a spot with bleeding and pus-like drainage.The patient had been on antibiotics however the doctor was concerned about the lack of healing and the potential for infection.Cultures were taken with no results known at this time.Surgical intervention was taken to explant the system.The patient was on antibiotics during the surgery and will continue antibiotics after going home.
|