BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEET TIP

    MDR report key: 1041451 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-32091
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    January 2, 2008
    Report Date
    January 2, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DXY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEET TIP IMPLANTABLE LEAD DXY CARDIAC PACEMAKERS, INC 4269 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other THE DEVICE 4285/209202 WAS IMPLANTED 30-AUG-1996| THE DEVICE 1296/104061 WAS IMPLANTED 12-OCT-2004