BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR, DF-4 CONNECTOR

    MDR report key: 3914595 · Received July 3, 2014

    Report

    Report Number
    2938836-2014-13099
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 4, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXHIBITED INAPPROPRIATE AUTO MODE SWITCH DUE TO COMPETITIVE ATRIAL PACING. THE DEVICE WAS REPROGRAMMED AND REMAINS IMPLANTED. PATIENT WAS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389868 ELLIPSE DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2411-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR