BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA ULTRA

    MDR report key: 1041611 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-31917
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    January 1, 2006
    Report Date
    February 29, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DXY
    Removal / Correction Number
    Z1293/99-6
    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 ULTRA IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS, INC 1291 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention THE DEVICE 4470/467392 WAS IMPLANTED 31-MAY-2006| THE DEVICE 1290/719057 WAS IMPLANTED 29-AUG-2005| THE DEVICE 4469/448091 WAS IMPLANTED 29-AUG-2005| THE DEVICE 4469/466383 WAS IMPLANTED 31-MAY-2006| THE DEVICE 4469/431904 WAS IMPLANTED 03-SEP-2004| THE DEVICE 4469/422372 WAS IMPLANTED 03-SEP-2004| THE DEVICE 4469/448040 WAS IMPLANTED 29-AUG-2005