BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAKIM INLINE PROGRAMMABLE VALVE SG

    MDR report key: 6697653 · Received July 10, 2017

    Report

    Report Number
    1226348-2017-10483
    Event Type
    Malfunction
    Date Received
    July 10, 2017
    Date of Event
    June 11, 2017
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K992173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE IMAGES WERE TAKEN OF THE ¿AS RECEIVED¿ VALVE. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 30MMH2O. THE VALVE WAS VISUALLY INSPECTED: NO DEFECTS WERE NOTED. THE VALVE WAS HYDRATED. THE SIPHON GUARD WAS TESTED. THE VALVE PASSED THE TEST. THE VALVE WAS TESTED FOR PROGRAMMING WITH PROGRAMMER 82-3126 WITH SERIAL NUMBER (B)(4), THE VALVE PASSED THE TEST. THE VALVE WAS FLUSHED, THE VALVE PASSED THE TEST NO OCCLUSION WAS NOTED. THE VALVE WAS LEAK TESTED, NO LEAKS NOTED. THE VALVE WAS REFLUX TESTED. THE VALVE PASSED THE TEST. THE VALVE WAS DRIED. THE VALVE WAS NOT PRESSURE TESTED AS THE PROBLEM WAS WITH THE SIPHON GUARD. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3162 WITH LOT CVKBR8, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK IN 23RD SEPTEMBER 2016. NO ROOT CAUSE COULD BE DETERMINED, AS THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    AS REPORTED BY THE SALES REP, 2 DAYS AFTER BEING IMPLANTED, AN INLINE PRECISION VALVE WAS REVISED BECAUSE IT WASN'T WORKING. THEY INITIALLY PLANNED TO IMPLANT A PROGRAMABLE INLINE VALVE, BUT THE SIPHONGUARD APPEARED NOT TO WORK, SO THEY PUT IT ASIDE AND IMPLANTED ANOTHER PROGRAMABLE INLINE VALVE INSTEAD. BOTH VALVES INVOLVED IN THIS INCIDENT WILL BE RETURNED. NO DELAYS OR ADVERSE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478155 HAKIM INLINE PROGRAMMABLE VALVE SG SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. 126510

    Patients

    Seq Age Sex Outcome Treatment
    1 825462