BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKER EDMS II

    MDR report key: 3922851 · Received July 9, 2014

    Report

    Report Number
    2021898-2014-00234
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K802100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS PATENT. HOWEVER IT DID NOT MEET THE REQUIREMENTS FOR LEAK TESTING DUE TO A CRACK IN THE PROXIMAL ARM OF THE PATIENT LINE STOPCOCK. THE NEEDLELESS INJECTION SITE ARM OF THE PATIENT LINE STOPCOCK WAS BROKEN. IT IS UNKNOWN HOW OR WHEN THIS DAMAGE OCCURRED. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT LINE 3 WAY STOPCOCK OF THE DEVICE WAS BROKEN. ACCORDING TO THE REPORT, THE PATIENT DID NOT INCUR AN INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400615 BECKER EDMS II SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 206735724

    Patients

    Seq Age Sex Outcome Treatment
    1