BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA ULTRA

    MDR report key: 1041517 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-32018
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    November 21, 2007
    Report Date
    January 24, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA ULTRA IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS, INC 1190 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention THE DEVICE 4457/533632 WAS IMPLANTED 30-OCT-2007