BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOPHY(R) ADJUSTABLE PRESSURE VALVE SHUNT

    MDR report key: 493387 · Received October 24, 2003

    Report

    Report Number
    3001587388-2003-00019
    Event Type
    Other
    Date Received
    October 24, 2003
    Date of Event
    October 1, 2003
    Report Date
    October 23, 2003
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IMPLANTATION IN 2003. INDICATION: HYDROCEPHALUS BY TUMOR, AND UNSATISFACTORY DRAINAGE. NEEDS TO MODIFY THE PRESSURE SETTING. IN 2003, EXPLANTATION DONE FOR A LOSE OF ADJUSTMENT CAPACITY OF THE VALVE AND REPLACEMENT WITH A NEW VALVE. NO INJURY REPORTED EXCEPT BEFORE OPERATION (TRANSIENT SYMPTOMS OF NEW HYDROCEPHALUS). THE PATIENT PRESENTED NO MORE NEUROLOGICAL TROUBLES AFTER OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOPHY(R) ADJUSTABLE PRESSURE VALVE SHUNT SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS JXG SOPHYSA SA * N0242

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other