BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAKIM INLINE PROGRAMMABLE VALVE SG

    MDR report key: 697074 · Received April 6, 2006

    Report

    Report Number
    1226348-2006-00072
    Event Type
    Malfunction
    Date Received
    April 6, 2006
    Date of Event
    March 7, 2006
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS
    Product Code
    JXG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE VALVE WAS EXPLANTED DUE TO A MALFUNCTION. NO OTHER DETAILS WERE AVAILABLE. SURGEON REVISED SHUNT WITH THE SAME PRODUCT CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM INLINE PROGRAMMABLE VALVE SG SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS NA PC1278

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other