BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA ULTRA

    MDR report key: 1253764 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40621
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 17, 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
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 47 YR Required Intervention THE DEVICE 4469/431008 WAS IMPLANTED 25-MAR-2005| THE DEVICE 4470/463284 WAS IMPLANTED 25-MAR-2005