BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XOMED PULSATRON II

    MDR report key: 276975 · Received May 5, 2000

    Report

    Report Number
    MW1018843
    Event Type
    Malfunction
    Date Received
    May 5, 2000
    Date of Event
    May 3, 2000
    Report Date
    May 5, 2000
    Manufacturer
    XOMED, INC.
    Product Code
    JXE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MALFUNCTION OF NERVE STIMULATOR CAUSED RT FACIAL NERVE TO BE SEVERED BY SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XOMED PULSATRON II NERVE STIMULATOR JXE XOMED, INC. * 113178-00

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other