BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO II VALVE WITH SIPHONGUARD

    MDR report key: 1664994 · Received April 15, 2010

    Report

    Report Number
    1664994
    Event Type
    Malfunction
    Date Received
    April 15, 2010
    Date of Event
    March 12, 2010
    Report Date
    April 15, 2010
    Manufacturer
    CODMAN AND SHURTLEFF INC
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAS HISTORY OF SHUNTED HYDROCEPHALUS WITH A CODMAN PROGRAMMABLE VALVE PROGRAMMED AT 70 WITH THE UNITIZED SIPHONGUARD. THE VALVE HAD BEEN IMPLANTED FOR ~2 MONTHS. PATIENT ADMITTED FOR MALFUNCTION OF THIS VALVE THAT REQUIRES REPLACEMENT. TAKEN TO SURGERY AND REPLACED SHUNT AND CODMAN VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO II VALVE WITH SIPHONGUARD PROGRAMMABLE VALVE JXG CODMAN AND SHURTLEFF INC NS5033 MA282

    Patients

    Seq Age Sex Outcome Treatment
    1 *