BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM VALVE

    MDR report key: 1924864 · Received December 9, 2010

    Report

    Report Number
    1226348-2010-00425
    Event Type
    Injury
    Date Received
    December 9, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    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 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 PT'S VENTRICLES BECAME ENLARGED. SURGEON CHANGED THE PRESSURE, BUT THE PT'S CONDITION DID NOT IMPROVE. IT WAS NOTED THAT FLUID DID NOT FLOW THROUGH THE DEVICE, WHICH REQUIRED A REVISION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention