BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA ULTRA

    MDR report key: 1043593 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33058
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 1, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DXY
    Removal / Correction Number
    Z0187-94/6
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA ULTRA IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS, INC 1290 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Other THE DEVICE 4457/456202 WAS IMPLANTED 25-FEB-2005| THE DEVICE 4471/419335 WAS IMPLANTED 25-FEB-2005