BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 1842069 · Received September 21, 2010

    Report

    Report Number
    1226348-2010-00297
    Event Type
    Injury
    Date Received
    September 21, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC., MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K974739
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFO IS NOT AVAILABLE FOR EVAL. THE DEVICE IS STILL IMPLANTED. WITHOUT THE DEVICE AND/OR LOT INFO IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFO DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A F/U REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE PT HAD REDUCED VENTRICLES AND AN INTRADURAL HEMATOMA. THE PT WAS SCANNED AND A PRESSURE READING OF 30MMH2O WAS CONFIRMED. IT WAS NOTED THAT AT THE TIME OF THE INITIAL IMPLANT THE DEVICE WAS NOT PROGRAMMED TO 30MMH2O. THE SURGEON ATTEMPTED TO CHANGE THE PRESSURE TO 200MMH2O AND WAS UNSUCCESSFUL. AT THAT POINT THE SURGEON WAS SUCCESSFUL IN CHANGING THE PRESSURE TO 130MMH2O BY USING NEODYMIUM. THE DEVICE REMAINS IMPLANTED AND THE PT IS UNDER OBSERVATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention