BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE VR, DF-4 CONNECTOR

    MDR report key: 4130784 · Received September 30, 2014

    Report

    Report Number
    2938836-2014-16160
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    August 13, 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
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE STRETCHING, THE PATIENT HEARD A LOUD POP SOUND AND AN ALERT FOR CHARGE TIME LIMIT BEING REACHED WAS OBSERVED. A MANUAL CHARGE WAS DONE ON THE CAPACITOR AND THE CHARGE TIME WAS WITHIN ACCEPTABLE LIMITS. PROGRAMMING CHANGES WERE MADE. THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607396 ELLIPSE VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1311-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR