BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA AVT

    MDR report key: 1043592 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33057
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    January 30, 2008
    Report Date
    February 1, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DXY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA AVT IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS, INC 1292 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other THE DEVICE 1292/114324 WAS IMPLANTED 30-JAN-2008