BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA ULTRA

    MDR report key: 1002414 · Received February 7, 2008

    Report

    Report Number
    2124215-2008-31899
    Event Type
    Injury
    Date Received
    February 7, 2008
    Date of Event
    September 22, 2007
    Report Date
    September 22, 2007
    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
    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 47 YR Required Intervention THE DEVICE 4087/276421 WAS IMPLANTED 22-SEP-2007| THE DEVICE 4470/302100 WAS IMPLANTED 30-AUG-2001| THE DEVICE 4086/245864 WAS IMPLANTED 22-SEP-2007| THE DEVICE 4471/300574 WAS IMPLANTED 30-AUG-2001| THE DEVICE 1291/140255 WAS IMPLANTED 22-SEP-2007| THE DEVICE 1283/619895 WAS IMPLANTED 30-AUG-2001| THE DEVICE 4088/212492 WAS IMPLANTED 05-OCT-2005| THE DEVICE 4087/276427 WAS IMPLANTED 22-SEP-2007