BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOPHY(R) ADJUSTABLE PRESSURE VALVE SHUNT

    MDR report key: 522206 · Received April 20, 2004

    Report

    Report Number
    3001587388-2004-00006
    Event Type
    Other
    Date Received
    April 20, 2004
    Date of Event
    September 24, 2003
    Report Date
    April 2, 2004
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2002, A SOPHYSA SHUNT WAS IMPLANTED TO THE PT FOR V-P SHUNTING. IN 2003, THE PT AFFECTED CONSCIOUSNESS DISORDER AND ONLY PERITONEAL CATHETER WAS REPLACED FOR V-A SHUNTING. THREE MONTHS LATER HYDROCEPHALUS WAS CONFIRMED AFTER NEW CONSCIOUSNESS DISORDERS. THEREFORE, THE NEUROSURGEON REMOVED THE VALVE DAYS LATER AND IMPLANTED ANOTHER BRAND-NAME VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOPHY(R) ADJUSTABLE PRESSURE VALVE SHUNT SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS JXG SOPHYSA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other