BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC XOMED

    MDR report key: 410474 · Received August 13, 2002

    Report

    Report Number
    MW1025812
    Event Type
    Other
    Date Received
    August 13, 2002
    Date of Event
    July 18, 2002
    Report Date
    August 6, 2002
    Manufacturer
    MEDTRONIC XOMED SURG PRODUCTS
    Product Code
    JXE
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CASE WAS LEFT PAROTIDECTOMY WITH NIM MONITORING SYSTEM. AT POINT OF WHEN READY TO MONITOR THE MACHINE HAD AN UNRELIABLE, FALLING LINE WAVEFORM. THE LINE SHOULD BE HORIZONTAL WHEN NOT DETECTING STIMULATION. BOTH MD'S AND NIM REP STATED THAT THE SAVE FORM AND INDICATOR WERE UNRELIABLE DUE TO BASE LINE WAVE FORM. THIS UNIT IS BEING REPLACED AND WILL NO LONGER BE USED. NO ADVERSE OUTCOME TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC XOMED NERVE INTEGRITY MONITORING SYSTEM JXE MEDTRONIC XOMED SURG PRODUCTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other