BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLARIS ADJUSTABLE PRESSURE VALVE SHUNT

    MDR report key: 694201 · Received March 30, 2006

    Report

    Report Number
    3001587388-2006-00007
    Event Type
    Other
    Date Received
    March 30, 2006
    Date of Event
    December 22, 2005
    Report Date
    March 23, 2006
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A LUMBO-PERITONEAL SHUNT WAS IMPLANTED IN A PATIENT WITH SET PRESSURE AT 110MM H2O. DOCTOR ATTEMPTED TO LOWER THE VALVE PRESSURE IN VAIN. THEN , HE TRIED UNDER FLUROSCOPIC WITH PUTTING MAGNET DIRECTLY ON THE PLANET BUT HE FAILED AGAN. THE SPV WAS EXPLANTED AND REPLACED BY ANOTHER VALVE IN 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS ADJUSTABLE PRESSURE VALVE SHUNT SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS JXG SOPHYSA SA POLARIS (R) VALVE R0257

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other