BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM VALVE

    MDR report key: 3894555 · Received June 25, 2014

    Report

    Report Number
    1226348-2014-11752
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 2, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK974739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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 CRBBCG SERIAL NUMBER (B)(4), PRODUCT CODE NS9008. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 60MMH2O. THE VALVE WAS VISUALLY INSPECTED A NEEDLE HOLE IN THE NEEDLE CHAMBER WAS NOTED, AS WELL AS A SLIT IN THE SILICONE HOUSING WAS FOUND OVER THE VALVE CASING. THE VALVE WAS IRRIGATED WITH PURIFIED WATER. NO OCCLUSION WAS NOTED. THE SIPHON GUARD WAS IRRIGATED WITH PURIFIED WATER, NO OCCLUSION WAS NOTED. THE CATHETERS WERE IRRIGATED WITH PURIFIED WATER. NO OCCLUSION WAS NOTED. THE VALVE WAS DRIED. THE VALVE WAS LEAK TESTED; THE VALVE ONLY LEAKED FROM THE HOLE IN THE NEEDLE CHAMBER. 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 WITH PRODUCT CODE NS9008, AND WITH LOT NUMBER CRBBCG CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 13TH FEBRUARY 2014. NO ROOT CAUSE COULD BE DETERMINED, AS THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED. THE SLIT IN THE SILICONE HOUSING COULD BE DUE TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE SILICONE HOUSING; THIS SLIT DID NOT SEEM TO AFFECT THE VALVES FUNCTIONS. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED VIA L-P SHUNT AT 160MMH2O TO THE PATIENT WITH NPH WHO HAD SUBARACHNOID HEMORRHAGE FOR THE SECOND TIME ON (B)(6) 2014. IT WAS FOUND THROUGH THE CONTRAST RADIOGRAPHY THAT THE VENTRICLES OF THE PATIENT¿S BRAIN REMAINED TO BE LARGE ON (B)(6) 2014. IT WAS NOTED THAT THE PATIENT HAD WALKING DISABILITY. THEREFORE, THE SETTING PRESSURE LOWERED TO 140MMH2O. ON (B)(6) 2014, THE SETTING PRESSURE LOWERED AGAIN TO 80MMH2O SINCE THE PATIENT¿S CONDITION WAS NOT IMPROVED. ON (B)(6) 2014, THE REVISION SURGERY WAS CONDUCTED DUE TO SUSPECTED OCCLUSION AND THE DEVICE WAS REPLACED WITH ANOTHER DEVICE (823100) VIA L-P SHUNT AT 100MMH2O. THE SETTING PRESSURE OF THE REMOVED VALVE WAS 80MMH2O. THE LUMBER CATHETER USED WITH NS9008 WAS MANUFACTURED BY OTHER COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371285 HAKIM VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF CRBBCG

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention