BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOPHY (R) ADJUSTABLE PRESSURE VALVE SHUNT WITH ANTECHAMBER

    MDR report key: 757835 · Received October 31, 2005

    Report

    Report Number
    3001587388-2005-00033
    Event Type
    Other
    Date Received
    October 31, 2005
    Date of Event
    October 6, 2005
    Report Date
    October 24, 2005
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SM8A VALVE HAS BEEN RETURNED FOR EVALUATION. ANALYSIS HAS TO BE DONE.

    Description of Event or Problem · 1

    THIS SOPHY ADJUSTABLE PRESSURE VALVE MODEL WITH ANTECHAMBER SM8-A WAS IMPLANTED INTHE PATIENT IN 2005. AS HYPODRAINAGE WAS OBSERVED, VALVE REVISION WAS OPERATED IN 2005. NO PATIENT INJURY IS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOPHY (R) ADJUSTABLE PRESSURE VALVE SHUNT WITH ANTECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS JXG SOPHYSA SA SOPHY (R) VALVE P0471

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other