BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 667344 · Received January 19, 2006

    Report

    Report Number
    9612007-2006-00004
    Event Type
    Malfunction
    Date Received
    January 19, 2006
    Report Date
    January 19, 2006
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    INTEGRA LIFE-SCIENCES CORPORATION BECAME AWARE OF THE FOLLOWING INCIDENT FROM THE PUBLICATION: "COMPLETE INTRAVENTRICULAR UNISYSTEM VENTRICULOPERITONEAL SHUNT MIGRATION." ONE PT PRESENTED WITH A COMPLETE SHUNT MIGRATION INTO THE LATERAL VENTRICLE AND WAS EXPLANTED. A NEW SHUNT WAS PLACED AND THE PT WAS DISCHARGED IN A STABLE CONDITION. THE PUBLICATION REFERS TO THE MIGRATION OF THE PERITONEAL CATHETER AS A "UNISHUNT SYSTEM, INTEGRA NEUROSCIENCES. THIS MIGHT BE THE OMNISHUNT VALVE AS USER FACILITY HAVE NO PRODUCT NAMED "UNISHUNT." NO PRODUCT ID OR LOT IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK DIFFERENTIAL PRESSURE VALVE SYSTEM JXG INTEGRA NEUROSCIENCES IMPLANTS S.A. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *