BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGAV PROGRAMMABLE SHUNT

    MDR report key: 2180629 · Received July 22, 2011

    Report

    Report Number
    2180629
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 30, 2011
    Manufacturer
    AESCULAP, INC.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD UNDERGONE PLACEMENT OF A VENTRICULOPERITONEAL SHUNT WITH PROGAV PROGRAMMABLE SHUNT VALVE EARLY LAST YEAR. DURING A FOLLOW-UP CHECK AT MD'S OFFICE, PATIENT COMPLAINING OF UNSTEADY GAIT AND NAUSEA. MD ATTEMPTED TO ADJUST THE CURRENT SETTING OF THE PROGRAMMABLE SHUNT VAVLE, BUT WAS UNABLE TO DO SO. MD MADE SEVERAL ATTEMPTS WITHOUT SUCCESS AND, THEREFORE, DECIDED TO TAKE PT TO OR FOR SHUNT VALVE REPLACEMENT. PT WAS TAKEN TO OR AND PROGAV PROGRAMMABLE SHUNT VALVE EXPLANTED AND ANOTHER VENDOR'S VALVE PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGAV PROGRAMMABLE SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG AESCULAP, INC. * 30018572

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR