BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR POROUS

    MDR report key: 1041985 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34668
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 19, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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 77 YR Other THE DEVICE 1226/245079 WAS IMPLANTED 14-FEB-1994| THE DEVICE 1290/808981 WAS IMPLANTED 19-MAR-2008| THE DEVICE 4135/282790 WAS IMPLANTED 19-MAR-2008| THE DEVICE 4261/044464 WAS IMPLANTED 14-FEB-1994