BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR POROUS

    MDR report key: 1043583 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33048
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    January 26, 2008
    Report Date
    January 28, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR POROUS IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4261 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention THE DEVICE 1294/946259 WAS IMPLANTED 09-AUG-2005| THE DEVICE 4136/244728 WAS IMPLANTED 26-JAN-2008| THE DEVICE 4469/441876 WAS IMPLANTED 09-AUG-2005