BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKER EDMS II

    MDR report key: 3885130 · Received June 19, 2014

    Report

    Report Number
    2021898-2014-00210
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 23, 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 PRODUCT HAS NOT BEEN RETURNED. THEREFORE AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE MET THE REQUIREMENTS FOR LEAK AND PATENCY TESTING. ALL OF THE CONNECTIONS ON THE DEVICE WERE SECURE. THEREFORE, THE CONDITIONS OF THE COMPLAINT COULD NOT BE DUPLICATED BY LABORATORY PERSONNEL. IT IS UNKNOWN WHAT CAUSED THE REPORTED EVENT. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THERE WAS DISCONNECTION AT THE 3 WAY STOPCOCK ON THE PATIENT LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361289 BECKER EDMS II SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 206899794

    Patients

    Seq Age Sex Outcome Treatment
    1