BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 369161 · Received January 2, 2002

    Report

    Report Number
    1223648-2002-00002
    Event Type
    Injury
    Date Received
    January 2, 2002
    Date of Event
    November 20, 2001
    Report Date
    December 5, 2001
    Manufacturer
    CODMAN & SHURTLEFF, INC./MODOS S.A.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE VALVE WAS EXPLANTED BECAUSE DUE TO FAILURE TO CEREBROSPINAL FLUID TO FLOW INTO THE DISTAL CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS JXG CODMAN & SHURTLEFF, INC./MODOS S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention