BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEET TIP RX

    MDR report key: 1043033 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33618
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 18, 2008
    Report Date
    February 18, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    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 SWEET TIP RX IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4244 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other THE DEVICE 1297/292281 WAS IMPLANTED 09-JAN-2004| THE DEVICE 4245/403935 WAS IMPLANTED 17-FEB-2000| THE DEVICE 4245/415129 WAS IMPLANTED 09-JAN-2004