BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM LATITUDE PROGRAMMER

    MDR report key: 1254167 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40736
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 19, 2008
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOOM LATITUDE PROGRAMMER PROGRAMMER LWS EXTERNAL MANUFACTURER 3120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other THE DEVICE E102/ WAS IMPLANTED| THE DEVICE 05 / WAS IMPLANTED| THE DEVICE 3120 WAS USED DURING THE EVENT.| THE DEVICE E102/001867 WAS IMPLANTED 18-SEP-2008