BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLARIS (R) ADJUSTABLE PRESSURE VALVE SHUNT

    MDR report key: 616152 · Received May 30, 2005

    Report

    Report Number
    3001587388-2005-00010
    Event Type
    Other
    Date Received
    May 30, 2005
    Date of Event
    March 24, 2005
    Report Date
    May 30, 2005
    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

    SPV WAS IMPLANTED IN THE PRECORDIA OF THE PATIENT FOR V-P SHUNTING. THE INITIAL SETTING PRESSURE WAS 110MMH2O. HOWEVER, THE VENTRICLE SHRINKING WAS OBSERVED AND THE DOCTOR CHANGED THE PRESSURE TO 150MMH2O. THOUGH THE PRESSURE WAS INCREASED, THE VENTRICLE SHRUNK MORE AND BECAME SLIT. THEN, THE DOCTOR INCREASED THE PRESSURE ONCE AGAIN TO 200MMH2O, BUT THE CONDITION WAS NOT IMPROVED. SINCE SUBDURAL EDEMA WAS OBSERVED, THE DOCTOR REMOVED THE SPV AND IMPLANTED SPV-400 WITH SETTING THE PRESSURE AT 300MMH2O. AFTER REPLACING THE VALVE, THE PATIENT RECOVERED AND LEFT THE HOSPITAL. NOT PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS (R) ADJUSTABLE PRESSURE VALVE SHUNT SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS JXG SOPHYSA SA POLARIS(R) VALVE P0366

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR