BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR POROUS

    MDR report key: 1253965 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40781
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 22, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR POROUS IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4271 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other THE DEVICE 1283/629877 WAS IMPLANTED 03-APR-2002| THE DEVICE 4473/305960 WAS IMPLANTED 03-APR-2002