BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA ENTRA

    MDR report key: 1043466 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33183
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 4, 2008
    Report Date
    March 24, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DXY
    Removal / Correction Number
    Z0187-94/6
    Adverse Event
    Yes
    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 INSIGNIA ENTRA IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS, INC 1294 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention THE DEVICE 4136/282594 WAS IMPLANTED 04-FEB-2008| THE DEVICE 1291/129867 WAS IMPLANTED 04-FEB-2008| THE DEVICE 4137/245470 WAS IMPLANTED 04-FEB-2008