BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW CONTROL VALVE, BURR HOLE, 16MM, MEDIUM PRESS.

    MDR report key: 230790 · Received June 30, 1999

    Report

    Report Number
    2021898-1999-00089
    Event Type
    Malfunction
    Date Received
    June 30, 1999
    Date of Event
    May 20, 1999
    Report Date
    June 3, 1999
    Manufacturer
    MEDTRONIC PS MEDICAL
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR ALWAYS PERFORMS A PRESSURE TEST WITH A MANOMETER AS RECOMMENDED BY PS MEDICAL.THE VALVE TESTED TOO HIGH-13-15 MM H20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOW CONTROL VALVE, BURR HOLE, 16MM, MEDIUM PRESS. Implant CENTRAL NERVOUS SYSTEM FLUID SHUNTS AND COMPONENTS JXG MEDTRONIC PS MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA