BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM

    MDR report key: 153369 · Received February 25, 1998

    Report

    Report Number
    1045254-1998-00001
    Event Type
    Injury
    Date Received
    February 25, 1998
    Date of Event
    January 7, 1998
    Manufacturer
    XOMED SURGICAL PRODUCTS
    Product Code
    IKW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    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."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIM NERVE INTEGRITY MONITOR IKW XOMED SURGICAL PRODUCTS NIM-2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Disability