BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA ENTRA

    MDR report key: 1042973 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33670
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 18, 2008
    Report Date
    February 18, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA ENTRA IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS, INC 1294 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention THE DEVICE 4137/282655 WAS IMPLANTED 05-FEB-2008| THE DEVICE 4136/282629 WAS IMPLANTED 05-FEB-2008| THE DEVICE 4470/572997 WAS IMPLANTED 19-FEB-2008