BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR, DF-4 CONNECTOR

    MDR report key: 4130766 · Received September 30, 2014

    Report

    Report Number
    2938836-2014-16132
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    August 12, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: THE REPORTED INABILITY TO INSERT THE ATRIAL LEAD WAS NOT CONFIRMED IN THE LABORATORY. VISUAL INSPECTION OF THE DEVICE HEADER NOTED THE ATRIAL LEAD PORT'S MID-SECTION WAS CLOUDY; HOWEVER THE TIP SECTION WAS TRANSPARENT. THE DEVICE WAS TESTED ON THE BENCH AND TEST LEADS WERE INSERTED AND ALL SET SCREWS WERE PROPERLY TIGHTENED. THE CAUSE OF THE REPORTED FIELD EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE ATRIAL LEAD COULD NOT BE FULLY INSERTED INTO THE ATRIAL PORT OF THE DEVICE HEADER. SILICONE OIL WAS USED BUT WAS UNSUCCESSFUL. A WHITE RESIDUE AND AN OPAQUE HEADER WERE NOTED. DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607391 ELLIPSE DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2411-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR 2088TC/CNY096144,