BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLIPSE DR

    MDR report key: 4173889 · Received October 15, 2014

    Report

    Report Number
    2938836-2014-16687
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    August 13, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NON SUSTAINED RIGHT VENTRICULAR OVERSENSING WAS OBSERVED THROUGH A REMOTE TRANSMISSION. THE PATIENT HAD COMPLAINTS OF DIZZINESS AND NUMBNESS IN LEGS, WHICH WERE CONCURRENT WITH THE TIME OF THE EPISODES. IT WAS NOTED THAT THE PATIENT HAD STOPPED TAKING ONE OF HIS MEDICATIONS, AND THAT WAS THOUGHT TO BE THE CAUSE OF THE SYMPTOMS. REPROGRAMMING CHANGES WERE ALSO MADE. THE PATIENT HAS BEEN FINE SINCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656252 ELLIPSE DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2311-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention