BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 515121 · Received March 10, 2004

    Report

    Report Number
    1226348-2004-00066
    Event Type
    Injury
    Date Received
    March 10, 2004
    Date of Event
    February 2, 2004
    Report Date
    February 19, 2004
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFFILIATE REPORTS PRE-OP X-RAY SHOWED VALVE OPENING PRESSURE OF 90 MM H2O. DURING THE SURGICAL PROCEDURE, THE INTRACRANIAL PRESSURE MEASURED 160-170 MM H2O USING A MANOMETER. AFTER A PERIOD OF TIME FOLLOWING VALVE IMPLANTATION, THE PT DID NOT FEEL WELL AND THE VALVE WAS EXPLANTED. AFFILIATE REPORTS THE VALVE OPENED AT 160-170 INSTEAD OF 90MM H2O.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER CNS SHUNT JXG CODMAN & SHURTLEFF, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention