BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAKIM PROGRAMMING VALVE

    MDR report key: 3921923 · Received July 9, 2014

    Report

    Report Number
    1226348-2014-11803
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 19, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK020667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. THE INVESTIGATION OF THE RETURNED DEVICE DID NOT CONFIRM THE PROBLEM REPORTED BY THE CUSTOMER. THE LOT NUMBER IS CRCCVZ SERIAL NUMBER (B)(4), PRODUCT CODE NS9009. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 180MMH2O. THE VALVE WAS VISUALLY INSPECTED; NO DEFECTS WERE NOTED. THE VALVE WAS IRRIGATED WITH PURIFIED WATER. NO OCCLUSION WAS NOTED. THE CATHETER WAS IRRIGATED WITH PURIFIED WATER, NO OCCLUSION WAS NOTED. THE VALVE WAS DRIED. THE VALVE WAS LEAK TESTED; NO LEAKS WERE NOTED. THE VALVE WAS REFLUX TESTED, THE VALVE PASSED THE TEST. THE VALVE WAS TESTED FOR PROGRAMMING; THE VALVE PASSED THE TEST. THE VALVE WAS THEN PRESSURE TESTED, THE VALVE PASSED THE TEST. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE, PRODUCT CODE NS9009 WITH LOT NUMBER CRCCVZ, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE (B)(6) 2014. NO ROOT CAUSE COULD BE DETERMINED, AS THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED. NO CORRECTIVE ACTION IS NEEDED BASED ON THE RESULTS OF THE EVALUATION. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER CONFIRMED THAT THE 2ND VALVE THAT WAS IMPLANTED WAS NOT REPLACED. CUSTOMER CONFIRMED THAT THE FIRST VALVE WAS IMPLANTED AND EXPLANTED INTRAOPERATIVLY. CUSTOMER DID NOT CONFIRM IF THE LUMBAR CATHETER WAS A CODMAN DEVICE, HOWEVER, IT IS LIKELY THAT THIS DEVICE IS NOT A CODMAN DEVICE THE CUSTOMER CONNECTED A LUMBAR CATHETER TO THE VALVE AND IS CONSIDERED OFF LABEL.

    Description of Event or Problem · 1

    L-P SHUNT FOR THE PATIENT WITH BRAIN HEMORRHAGE WAS CONDUCTED ON (B)(6) 2014. WHEN THE SURGEON CONNECTED THE LUMBAR CATHETER TO THE VALVE AND TRIED PUMPING, THE SURFACE OF DOME GOT BACK TO THE ORIGINAL POSITION SO SLOWLY AND THE OCCLUSION AT THE LUMBAR SIDE WAS SUSPECTED. WHEN PULLING BACK THE LUMBAR CATHETER ABOUT 1 CM, THE FLUID FLOWED FROM THE DISTAL END OF THE LUMBAR CATHETER WITHOUT PROBLEM. THE SURGEON RECONNECTED IT TO THE VALVE AND PUMPED AGAIN, BUT IT WAS NOTED SAME PHENOMENON WITH THE DOME. HE SUSPECTED THE DEFECT WITH THE INTEGRATED PART OF CATHETER TO THE VALVE. HE REPLACED THE DEVICE WITH THE NEW PRODUCT (NS9009) AND COMPLETE THE CASE THOUGH THE SAME FAILURE WAS NOTED AGAIN WITH THE REPLACED VALVE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401411 HAKIM PROGRAMMING VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF CRCCVZ

    Patients

    Seq Age Sex Outcome Treatment
    1