BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NPH LOW FLOW VALVE

    MDR report key: 596913 · Received April 28, 2005

    Report

    Report Number
    9612007-2005-00010
    Event Type
    Malfunction
    Date Received
    April 28, 2005
    Report Date
    April 28, 2005
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    INTEGRA NEUROSPECIALIST REPORTED FOR THE USER FACILITY THE FOLLOWING INCIDENT: INTEGRA NPH LOW FLOW VALVE WAS IMPLANTED A PT ON 12/2004. THEIR SYMPTOMS EASED. THEY RESUMED NORMAL ACTIVITIES. HOWEVER, AFTER ABOUT 2 MONTHS OF THE SURGERY, PT'S HYDROCEPHALIC SYMPTOMS STARTED TO COME BACK. SINCE THE NPH VALVE WAS SELF ADJUSTING AND OPERATED ON A SELF FLOW RATE, THE SURGEON FELT LIMITED TO CONTROL THE VALVE. THE DEVICE WAS THEN REMOVED FROM THE PT. DEVICE WAS DISCARDED BY THE USER FACILITY AND WILL NOT BE AVAILABLE FOR THE INVESTIGATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NPH LOW FLOW VALVE LOW FLOW OSV II VALVE JXG INTEGRA NEUROSCIENCES IMPLANTS S.A. * 130723

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention