BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE VR

    MDR report key: 3220319 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04436
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    May 16, 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
    IL
    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 BEING UNABLE TO SECURE A LEAD WITH THE RV SET SCREW WAS CONFIRMED IN THE LABORATORY. THE RV SET SCREW BORE HAD EXCESS EPOXY AT THE BOTTOM, WHICH IS BELIEVED TO HAVE PREVENTED THE SET SCREW FROM TIGHTENING ALL THE WAY AND PREVENTED THE SET SCREW FROM SECURING THE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING DEVICE CHANGE OUT FOR NORMAL ERI, WHEN THE CHRONIC LEAD WAS CONNECTED TO THE NEW DEVICE, THE PHYSICIAN WAS UNABLE TO SECURE THE LEAD INTO THE HEADER. THE DEVICE WAS NOT IMPLANTED AND WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320283 ELLIPSE VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD1311-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR