BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR POROUS

    MDR report key: 1042572 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34079
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 4, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 85 YR Required Intervention THE DEVICE 1298/211784 WAS IMPLANTED 24-AUG-2005| THE DEVICE 4092/LEP026 WAS IMPLANTED 08-MAR-2000