BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM V-C 60CM

    MDR report key: 1071320 · Received July 8, 2008

    Report

    Report Number
    1226348-2008-00180
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    June 9, 2008
    Manufacturer
    CODMAN & SHURTLEFF, INC/MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K020667
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    VENTRICULAR CATHETER MOVED TO DISTAL POSITION AFTER IMPLANTATION AND CAME OFF FROM THE BRAIN VENTRICLE. IT WAS REPLACED IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM V-C 60CM SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC/MEDOS S.A. NA CHHBYD

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention