BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR, DF-4 CONNECTOR

    MDR report key: 3903659 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12840
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 23, 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
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. POST-PACED T-WAVE OVERSENSING ON THE VENTRICULAR CHANNEL WAS OBSERVED. ONE AMS EPISODE SHOWED HIGH AMPLITUDE NOISE THAT APPEARED ONLY ON THE VENTRICULAR SENSE AMP CHANNEL, HOWEVER NOISE WAS NOT BEING SENSED. PROGRAMMING CHANGES WERE MADE. PATIENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380245 ELLIPSE DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2311-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR