BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOPHY SM8 PROG. VALVE / ANTECHAMBER

    MDR report key: 3170731 · Received May 22, 2013

    Report

    Report Number
    3001587388-2012-00455
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    October 22, 2010
    Report Date
    May 21, 2013
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE LABORATORY ANALYSIS OF THE VALVE WILL BE SENT TO COMPLETE THIS INCIDENT REPORT.

    Description of Event or Problem · 1

    THE CHILDREN WITH IMPLANTED SHUNT SYSTEM (THE PRESSURE WAS ADJUSTED AT 30MM H2O) HAD A PERMANENT HYPO DRAINAGE WITH HIGH INTRACRANIAL PRESSURE AND THE DETERIORATION OF CONDITION WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226985 SOPHY SM8 PROG. VALVE / ANTECHAMBER SOPHY SM8 PROG. VALVE / ANTECHAMBER JXG SOPHYSA SA SOPY Z0199

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR