BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE VR, DF-4 CONNECTOR

    MDR report key: 3781781 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-09930
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    March 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
    OR, 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 THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP WITH DEVICE IN BACKUP VVI MODE. A DEVICE CODE WAS DOWNLOAD SUCCESSFULLY AND THE DEVICE WAS RESTORED TO NORMAL OPERATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260292 ELLIPSE VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1411-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR