BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRA NPH LOW FLOW VALVE

    MDR report key: 2854155 · Received November 28, 2012

    Report

    Report Number
    9612007-2012-00038
    Event Type
    Injury
    Date Received
    November 28, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 28, 2012
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K042192
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION, AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    A PATIENT EXPERIENCED UNDERDRAINAGE WITH THE USE OF AN INTEGRA NPH LOW FLOW VALVE WITHOUT A RESERVOIR. THE VALVE WAS REPLACED BY A PROGRAMMABLE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRA NPH LOW FLOW VALVE NPH LOW FLOW VALVE JXG INTEGRA NEUROSCIENCES IMPLANTS S.A. SEE LIST

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention