BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE PICOTIP LEAD

    MDR report key: 1043550 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33099
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 2, 2008
    Report Date
    February 2, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELUTE PICOTIP LEAD IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4035 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention THE DEVICE 1280/552951 WAS IMPLANTED 16-MAY-2005| THE DEVICE 4271/232322 WAS IMPLANTED 14-FEB-2000