BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR

    MDR report key: 4173895 · Received October 15, 2014

    Report

    Report Number
    2938836-2014-16719
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 9, 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
    MS, 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 WHEN THE PATIENT PRESENTED OR ROUTINE DEVICE CHECKUP, THE PATIENT NOTIFIER WOULD NOT VIBRATE. ATTEMPTS FROM USING RADIO FREQUENCY TELEMETRY AND REPROGRAMMING THE VIBRATION DURATION WERE UNSUCCESSFUL. THE PATIENT WILL CONTINUE TO BE MONITORED. THE PATIENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655765 ELLIPSE DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2311-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR