BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOPHY ADJUSTABLE PRESSURE VALVE SHUNT

    MDR report key: 501934 · Received December 9, 2003

    Report

    Report Number
    3001587388-2003-00025
    Event Type
    Other
    Date Received
    December 9, 2003
    Date of Event
    July 5, 2003
    Report Date
    December 9, 2003
    Manufacturer
    SOPHYSA SA
    Product Code
    JQG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    2003, A SOPHYSA SHUNT WAS IMPLANTED TO A PATIENT. THE SOPHYSA SHUNT WAS COMPOSED OF ONE SOPHY ADJUSTABLE PRESSURE VALVE (CAT.#SM8), ONE VENTRICULAR CATHETER (CAT.#PL06), AND ONE PERITONEAL CATHETER (CAT.#B905S). SOME TROUBLES APPEAR FOR THE PATIENT WITH FEVER AND VOMITING. THE REVISION WAS OPERATED AND ANALYSIS SHOWED INFECTION WITH PSEUDOMONAS AERUGINOSA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOPHY ADJUSTABLE PRESSURE VALVE SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JQG SOPHYSA SA * N0022

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other VENTRICULAR CATHER (CAT. #PLO6)| PERITONEAL CATHETER (CAT.#B905S)