BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EURO BECKER EDMS II

    MDR report key: 2192696 · Received July 20, 2011

    Report

    Report Number
    2021898-2011-00163
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 20, 2011
    Report Date
    July 1, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K984053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR. THEREFORE, AN EVAL OF THE DEVICE WAS NOT POSSIBLE. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT ALLEGEDLY A BROKEN PT LINE STOPCOCK CAUSED A CSF LEAKAGE AND SUDDEN DECREASE IN INTERCRANIAL PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EURO BECKER EDMS II JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 11327128

    Patients

    Seq Age Sex Outcome Treatment
    1