BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE

    MDR report key: 1253613 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40029
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 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 74 YR Required Intervention THE DEVICE 1190/129509 WAS IMPLANTED 06-OCT-2005| THE DEVICE 1232/200868 WAS IMPLANTED 24-JAN-1997| THE DEVICE 1194/116336 WAS IMPLANTED 06-JAN-2004| THE DEVICE 4271/206892 WAS IMPLANTED 24-JAN-1997| THE DEVICE 01 / WAS IMPLANTED| THE DEVICE 4285/218043 WAS IMPLANTED 24-JAN-1997