BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITRELL II NEURO PULSE GENERATOR

    MDR report key: 34022 · Received July 11, 1996

    Report

    Report Number
    MW1009476
    Event Type
    Malfunction
    Date Received
    July 11, 1996
    Date of Event
    June 18, 1996
    Report Date
    July 1, 1996
    Manufacturer
    NEUROLOGICAL DIV. METRONIC, INC.
    Product Code
    GZB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NEURO PULSE GENERATOR NOT WORKING. IT HAD BEEN READJUSTED AND CHECKED BEFORE IT WAS DECIDED THAT IT HAS TO BE REPLACED. NO INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITRELL II NEURO PULSE GENERATOR Implant NEURO PULSE GENERATOR GZB NEUROLOGICAL DIV. METRONIC, INC. 7424 ITREL II NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other