BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOPHY ADJUSTABLE PRESSURE VALVE SHUNT

    MDR report key: 492243 · Received October 14, 2003

    Report

    Report Number
    3001587388-2003-00016
    Event Type
    Other
    Date Received
    October 14, 2003
    Date of Event
    June 4, 2003
    Report Date
    October 14, 2003
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IMPLANTATION OF SOPHY VALVE WITH ANTECHAMBER IN 2002 FOR TUMOR HYDROCEPHALUS. EXPLANTATION IN 2003 FOR DISCONNECTION OF THE RESERVOIR FROM THE VALVE AFTER CLINICAL AND XRAY DIAGNOSIS. EXPLANTATION OF THE IMPLANT AND REPLACEMENT WITH A NEW SOPHY VALVE. NO INJURY REPORTED EXCEPTED TRANSIENT NEUROLOGICAL COMPLICATIONS BEFORE REPLACEMENT OF THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOPHY ADJUSTABLE PRESSURE VALVE SHUNT SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS JXG SOPHYSA * M0089

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other