BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2180630 · Received July 22, 2011

    Report

    Report Number
    2180630
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 22, 2011
    Manufacturer
    CODMAN & SHURTLEFF, 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 THE LUMBAR-PERITONEAL (LP) SHUNT VALVE IMPLANTED 5-8 YEARS AGO. PATIENT RECENTLY BEGAN HAVING HEADACHES AND THE VALVE WAS REPOSTIONED IN SURGERY RECENTLY. MD STATED THAT HE WAS UNABLE TO REPROGRAM THE SHUNT AND RETURNED THE PATIENT TO THE OR 5 DAYS LATER AND EXPLANTED THE SHUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG CODMAN & SHURTLEFF, INC 82-3854 *

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR