BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR

    MDR report key: 3090094 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01203
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    March 8, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF BEING ABLE TO INSERT THE ATRIAL LEAD INTO THE HEADER OF THE DEVICE WAS NOT CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND TEST LEADS INSERTED AND SECURED WELL INTO THE HEADER. THE LEAD BORE DIAMETERS WERE TESTED AND WERE FOUND TO BE WITHIN PRODUCT SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE OPERATING ROOM FOR CHANGE OUT DUE TO NORMAL ERI. UPON IMPLANT, THE PHYSICIAN WAS UNABLE TO INSERT THE ATRIAL LEAD INTO THE HEADER OF THE DEVICE. THE DEVICE WAS REPLACED AND NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191145 ELLIPSE DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2311-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR