BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKER EDMS II

    MDR report key: 2934497 · Received January 11, 2013

    Report

    Report Number
    2021898-2013-00011
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 18, 2012
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K802100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LUER CONNECTOR ATTACHED TO THE PROXIMAL END OF THE 12" BLUE LINE TUBING WAS SIGNIFICANTLY BENT. IT IS UNKNOWN HOW OR WHEN THIS DAMAGE OCCURRED. HOWEVER, THE DAMAGE IS LIKELY ATTRIBUTABLE TO HAVING BEING TORQUED BY AN ATTACHED CATHETER. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT'S MOTHER ATTENDED TO THE PATIENT AT APPROXIMATELY 0130, AT WHICH TIME THE DEVICE WAS INTACT AND THE PATIENT RETURNED TO SLEEP. THE REPORT BY THE PATIENT'S NURSE THEN STATES THAT AT 0215 THE PATIENT WAS FOUND DISCONNECTED FROM THE DEVICE AFTER BEING ALERTED BY THE PATIENT'S LOW OXYGEN SATURATION ALARM. ACCORDING TO THE REPORT, IT IS UNCLEAR WHETHER THE PATIENT PULLED THE DEVICE TUBING OR IF IT BROKE WHEN THEY ROLLED WHILE SLEEPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17170 BECKER EDMS II JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 206117184

    Patients

    Seq Age Sex Outcome Treatment
    1