BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM IN LINE PROGRAMMABLE VALVE

    MDR report key: 1961098 · Received January 12, 2011

    Report

    Report Number
    1226348-2011-00006
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    November 30, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HISTORICALLY, FOR COMPLAINTS OF THIS NATURE, EXAMS OF THE VALVES HAVE REVEALED THE PRESENCE OF BIOLOGICAL DEBRIS WITHIN THE DEVICES WHICH HAVE INTERFERED WITH THEIR PROGRAMMING AND/OR PRESSURE CONTROL MECHANISMS. THE BIOLOGICAL DEBRIS HAS CAUSED THE RETURNED VALVES TO FAIL THE PROGRAMMING AND/OR PRESSURE TESTS AND APPEARS TO HAVE CAUSED THE DIFFICULTIES EXPERIENCED BY THE CUSTOMERS. REVIEWS OF THE DEVICE HISTORY RECORDS HAVE CONFIRMED THAT THE VALVES HAVE MET SPECIFICATIONS WHEN RELEASED TO STOCK. A F/U 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 CONSIDERED TO BE CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE VALVE WAS IMPLANTED IN A PT LAST YR. AT THE END OF NOV THE PT STARTED FEELING SYMPTOMATIC WITH HEADACHES AND VOMITING. IT WAS ALSO NOTED THAT THE VALVE COULD NOT BE PROGRAMMED, SO PT UNDERWENT A NEW SURGERY TO REPLACE THE VALVE WITH A NEW ONE. DURING THE OPERATION SURGEON FOUND OUT THAT THE DEVICE WAS BROKEN. NOW THE PT SEEMS TO BE IN GOOD HEALTH CONDITION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention