BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 1201484 · Received October 17, 2008

    Report

    Report Number
    1226348-2008-00279
    Event Type
    Injury
    Date Received
    October 17, 2008
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CODMAN HAS REQUESTED RETURN OF THE VALVE FOR EVAL. HISTORICALLY, FOR COMPLAINTS OF THIS NATURE, EXAMINATIONS OF THE VALVES HAVE REVEALED THE ACCUMULATIONS OF BIOLOGICAL DEBRIS WITHIN THE VALVES, WHICH HAVE RESULTED IN BLOCKAGES WITHIN THE DEVICES. REVIEWS OF THE DEVICE HISTORY RECORDS HAVE CONFIRMED THAT THE VALVES HAVE MET SPECIFICATIONS WHEN RELEASED TO STOCK. A FOLLOW UP REPORT WILL BE FILED IF THE INVESTIGATION OF THIS DEVICE REVEALS A RESULT DIFFERENT FROM THAT WHICH IS STATED ABOVE OR IF ANY FURTHER INFO REGARDING THE CAUSE OR MODE OF FAILURE IS MADE AVAILABLE. OTHERWISE, THE COMPLAINT IS CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE VALVE DID NOT HOLD THE PROGRAMMABLE OPENING PRESSURE. COLLAPSED VENTRICULAR SYSTEM AND SECONDARY PROXIMAL OBSTRUCTION. AN OPERATION WAS NECESSARY DUE TO PROXIMAL OBSTRUCTION. CONTROL OF THE VALVE SHOWED NO OPENING PRESSURE, BUT THE VALVE HAD THE OPENING PRESSURE 14 PROGRAMMED SEVERAL YEARS EARLIER. AFTER THE REMOVAL OF THE VALVE, A RADIOGRAPHIC CONTROL SHOWED 14 CM OPENING PRESSURE.

    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 PBS450

    Patients

    Seq Age Sex Outcome Treatment
    1 3.5 YR Required Intervention