BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR, DF4 CONNECTOR

    MDR report key: 3101170 · Received May 9, 2013

    Report

    Report Number
    2938836-2013-01969
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    January 25, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED FIELD EVENT OF DIFFICULTY INSERTING THE ATRIAL LEAD WAS CONFIRMED IN THE LABORATORY. ANALYSIS OF THE DEVICE FOUND EPOXY ON THE ATRIAL RING SPRING. THE EPOXY IS BELIEVED TO HAVE BEEN OBSTRUCTING FULL ENTRY OF THE LEAD INTO THE ATRIAL BORE DURING THE ATTEMPTED IMPLANT IN THE FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT IMPLANT, THE LEAD COULD NOT BE INSERTED INTO THE ATRIAL PORT OF THE DEVICE. A SECOND LEAD WAS USED WITH THE SAME RESULTS. THE DEVICE WAS NOT IMPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203430 ELLIPSE DR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2311-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR