BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVERY II DR

    MDR report key: 1042074 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34561
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 13, 2008
    Report Date
    March 13, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DXY
    Removal / Correction Number
    Z875/897-3
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISCOVERY II DR IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS, INC 1284 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention THE DEVICE 4087/151189 WAS IMPLANTED 18-OCT-2002| THE DEVICE 4470/556429 WAS IMPLANTED 13-MAR-2008| THE DEVICE 4086/107863 WAS IMPLANTED 18-OCT-2002| THE DEVICE 1294/960148 WAS IMPLANTED 13-MAR-2008