BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA ULTRA

    MDR report key: 1043543 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33092
    Event Type
    Injury
    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
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 4087/257153 WAS IMPLANTED 14-JUN-2007| THE DEVICE 4086/233389 WAS IMPLANTED 14-JUN-2007