BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA PLUS

    MDR report key: 1043172 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33477
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    December 18, 2007
    Report Date
    February 13, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA PLUS IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS, INC 1297 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention THE DEVICE 4136/282543 WAS IMPLANTED 26-NOV-2007| THE DEVICE 4137/282546 WAS IMPLANTED 26-NOV-2007