BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR, DF-4 CONNECTOR

    MDR report key: 4240736 · Received November 10, 2014

    Report

    Report Number
    2938836-2014-17723
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 3, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-SENSED T-WAVE OVERSENSING WAS OBSERVED VIA A MERLIN.NET TRANSMISSION. THE DEVICE WAS REPROGRAMMED. THERE WERE NO ADVERSE EVENTS FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723594 ELLIPSE DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2411-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR