BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA PLUS

    MDR report key: 1043092 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33564
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 16, 2008
    Report Date
    February 16, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DXY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 61 YR Other THE DEVICE 4459/446594 WAS IMPLANTED 15-FEB-2008| THE DEVICE 4479/ WAS IMPLANTED| THE DEVICE 4480/492443 WAS IMPLANTED 15-FEB-2008| THE DEVICE 4480/ WAS IMPLANTED