BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE PICOTIP LEAD

    MDR report key: 1043487 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33148
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 5, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 Required Intervention THE DEVICE 1291/145721 WAS IMPLANTED 28-JAN-2008| THE DEVICE 4244/443462 WAS IMPLANTED 28-JAN-2008