BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR, DF-4 CONNECTOR

    MDR report key: 3943851 · Received July 18, 2014

    Report

    Report Number
    2938836-2014-13408
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 14, 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
    AU
    Reporter Occupation
    PHYSICIAN

    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 THE PATIENT CAME INTO THE CLINIC AFTER RECEIVING AN ALERT. UPON INTERROGATION AN ALERT FOR MAXIMUM CHARGE TIME REACHED WAS OBSERVED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. MANUAL CAPACITOR MAINTENANCE WAS DONE AND THE DEVICE RETURNED TO NORMAL ACCEPTABLE VALUES. THE PATIENT WILL BE FOLLOWED UP AS USUAL AND WAS STABLE AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421483 ELLIPSE DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2377-36QC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR