BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR, DF-4 CONNECTOR

    MDR report key: 3884740 · Received June 19, 2014

    Report

    Report Number
    2938836-2014-12135
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 21, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THE REPORTED FIELD EVENTS OF AN ATRIAL SET SCREW ANOMALY, NO CAPTURE, NO OUTPUT, AND HIGH PACING LEAD IMPEDANCE WERE NOT CONFIRMED IN THE LABORATORY. THE ATRIAL SET SCREW WAS FOUND TO BE NORMAL WHEN TESTED ON THE BENCH. A TORQUE DRIVER WAS ABLE TO ENGAGE AND TIGHTEN THE ATRIAL SET SCREW IN ORDER TO SECURE THE TEST LEAD.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT A SENSING ANOMALY WAS ALSO OBSERVED DURING ATTEMPTED IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, HIGH PACING LEAD IMPEDANCE WAS OBSERVED AFTER THE ATRIAL LEAD WAS INSERTED INTO THE DEVICE. AN ATRIAL SET SCREW ANOMALY, NO CAPTURE, AND NO OUTPUT WERE ALSO NOTED. ANOTHER DEVICE WAS IMPLANTED WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361255 ELLIPSE DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2411-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR