Device 1 of 2.Reference mfr.Report#: 1627487-2015-05542.On (b)(6) 2015, the patient underwent a permanent implant procedure.The patient began to stop breathing after the leads were placed and were in the process of being anchored.In turn, the patient was flipped over on her back to re-establish her airway.The procedure was resumed once the patient was stabilized, but both leads had become contaminated.As a result, the doctor removed and replaced both leads.The procedure was completed successfully after being extended by an hour.
|