BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA ENTRA

    MDR report key: 1043415 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33216
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 7, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DXY
    Removal / Correction Number
    Z0187-94/6
    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 ENTRA IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS, INC 1296 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention THE DEVICE 432-/68519R WAS IMPLANTED 17-JUN-1996| THE DEVICE 404-/OMG102 WAS IMPLANTED 23-AUG-1991| THE DEVICE 284-/23979 WAS IMPLANTED 23-AUG-1991| THE DEVICE 430-/63892D WAS IMPLANTED 23-AUG-1991| THE DEVICE 294-/02161 WAS IMPLANTED 17-JUN-1996