BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR

    MDR report key: 3884676 · Received June 19, 2014

    Report

    Report Number
    2938836-2014-12107
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    April 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
    MI, 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 THAT AN ALERT FOR LONG CHARGE TIME WAS OBSERVED. THE CHARGE TIME WAS RE-MEASURED AND FOUND TO BE NORMAL. IT WAS NOTED THAT THE DEVICE MAY HAVE BEEN KEPT IN A COLD ENVIRONMENT SEVERAL MONTHS PRIOR TO IMPLANT AND MAY HAVE AFFECTED THE CHARGE TIME. THE DEVICE REMAINS IMPLANTED, AND PATIENT WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361124 ELLIPSE DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2411-36C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR