BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA NSC VALVE REGULAR

    MDR report key: 2061408 · Received April 7, 2011

    Report

    Report Number
    2061408
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 7, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS SYMPTOMATIC WITH BALANCE ISSUES AND HEADACHES THUS HE CAME INTO THE HOSPITAL. NUCLEAR MEDICINE SCINTIGRAM IDENTIFIED SHUNT AS MALFUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA NSC VALVE REGULAR SHUNT, VENTRICULAR JXG MEDTRONIC NEUROSURGERY 42365 C79302

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR