BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 2381237 · Received December 19, 2011

    Report

    Report Number
    1226348-2011-00494
    Event Type
    Injury
    Date Received
    December 19, 2011
    Date of Event
    November 12, 2011
    Manufacturer
    CODMAN AND SHURTLEFF - MEDOS
    Product Code
    JXG
    PMA / PMN Number
    K980778
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HISTORICALLY, FOR COMPLAINTS OF THIS NATURE, EXAMINATIONS 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 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 INFORMATION REGARDING THE CAUSE OR MODE OF FAILURE IS MADE AVAILABLE. OTHERWISE, THE COMPLAINT IS CONSIDERED TO BE CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PRODUCT CODE IS ACTUALLY THAT OF 82-3114 AND NOT THAT OF 82-3112 AS REPORTED IN THE INITIAL MEDWATCH REPORT. EXAMINATION OF THE VALVE DETERMINED THAT BIOLOGICAL DEBRIS WITHIN THE DEVICE LIKELY CAUSED THE DIFFICULTY EXPERIENCED BY THE CUSTOMER. THIS BIOLOGICAL DEBRIS WAS DISLODGED DURING FLOW TESTING OF THE RETURNED VALVE. AFTER DISLODGING, THE VALVE PASSED THE PRESSURE TESTS BUT NOT THE PROGRAMMING. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE VALVE MET SPECIFICATIONS WHEN RELEASED TO STOCK. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    VALVE COULD NOT BE REPROGRAMMED AND AS A RESULT IT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM PROGRAMMABLE VALVE CNS SHUNT JXG CODMAN AND SHURTLEFF - MEDOS CLKB0V

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention