BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOPHY ADJUSTABLE PRESSURE VALVE SHUNT

    MDR report key: 480004 · Received August 18, 2003

    Report

    Report Number
    3001587388-2003-00008
    Event Type
    Other
    Date Received
    August 18, 2003
    Report Date
    August 18, 2003
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EXPLANTATION IN 2003 FOR SUSPECTED OVERDRAINAGE ON HIGH PRESSURE SETTING. (MORE INFO WERE ASKED A FEW TIMES TO THE NEUROSURGEON FROM MAY 2003 WITHOUT SUCCESS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOPHY ADJUSTABLE PRESSURE VALVE SHUNT SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS JXG SOPHYSA * L0199

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other