BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR

    MDR report key: 3854664 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11583
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    April 2, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOW R-WAVES WERE OBSERVED ON THE DEVICE VIA A MERLIN.NET TRANSMISSION. MYOPOTENTIAL OVERSENSING WAS SUSPECTED. PROGRAMMING CHANGES WERE MADE AND WAS SUCCESSFUL. NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330748 ELLIPSE DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2377-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1