BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR, DF-4 CONNECTOR

    MDR report key: 3892648 · Received June 24, 2014

    Report

    Report Number
    2938836-2014-12283
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    April 16, 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
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MERLIN.NET TRANSMISSION SHOWED EPISODES OF NON-SUSTAINED LEAD NOISE DUE TO POST-PACED T-WAVE OVERSENSING ON THE VENTRICULAR CHANNEL. THE PATIENT WAS ASYMPTOMATIC. PROGRAMMING CHANGES WERE RECOMMENDED BUT NOT MADE. SUBSEQUENTLY, A SECOND TRANSMISSION WAS RECEIVED SHOWING THE NON-SUSTAINED LEAD NOISE AND POST-PACED T-WAVE OVERSENSING CONTINUED. RECOMMENDED PROGRAMMING CHANGES ARE PLANNED FOR NEXT IN-CLINIC FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368568 ELLIPSE DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2311-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR