BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM IN LINE PROGRAMMABLE VALVE

    MDR report key: 1221253 · Received November 5, 2008

    Report

    Report Number
    1226348-2008-00299
    Event Type
    Injury
    Date Received
    November 5, 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 Location
    JA
    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 SPECS 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 CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT FLUID DID NOT FLOW THROUGH THE DEVICE DUE TO SOME FORM OF BLOCKAGE AND NEEDED TO BE REPLACED. THE DEVICE WAS IMPLANTED IN 2008 AND REPLACED AT APPROXIMATELY 64 DAYS LATER.

    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 HF774

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention