BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA ULTRA

    MDR report key: 1042970 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33667
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 18, 2008
    Report Date
    February 18, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    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 72 YR Required Intervention THE DEVICE 4136/282651 WAS IMPLANTED 18-FEB-2008| THE DEVICE 4136/282505 WAS IMPLANTED 23-NOV-2007| THE DEVICE 4479/440835 WAS IMPLANTED 23-NOV-2007