InjuryIKW
NIM
Received Feb 25, 1998 · Event occurred Jan 7, 1998
Report 1045254-1998-00001 · MDR key 153369
Device
Generic name
Nerve Integrity Monitor
Manufacturer
Xomed Surgical ProductsModel number
NIM-2Catalog number
8220100
Lot number
*
Patient
43 YR
Narrative
Description of Event or Problem
IT WAS REPORTED BY USER FACILITY THAT; "PT UNDERWENT TYMPANOMASTOIDECTOMY PROCEDURE, DURING WHICH A NERVE INTEGRITY MONITOR WAS USED TO HELP PREVENT NERVE DAMAGE. UPON AWAKENING FROM ANESTHESIA FOLLOWING THE PROCEDURE, THE PT WAS FOUND TO HAVE FACIAL PARESIS."