BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE

    MDR report key: 1041954 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34693
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 21, 2008
    Report Date
    March 21, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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 SELUTE IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4285 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention THE DEVICE 1190/161245 WAS IMPLANTED 21-MAR-2008| THE DEVICE 4137/244710 WAS IMPLANTED 21-MAR-2008| THE DEVICE 1181/303893 WAS IMPLANTED 01-APR-2002| THE DEVICE 1130/251449 WAS IMPLANTED 24-OCT-1997