BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAKIM INLINE PROGRAMMABLE VALVE SG

    MDR report key: 5538688 · Received March 31, 2016

    Report

    Report Number
    1226348-2016-10249
    Event Type
    Malfunction
    Date Received
    March 31, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    PK992173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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 HYDRATED FOR ABOUT 26 HOURS. THE VALVE WAS VISUALLY INSPECTED: NO DEFECTS WERE NOTED. THE VALVE WAS TESTED FOR PROGRAMMING WITH PROGRAMMER 82-3126 WITH SERIAL NUMBER (B)(4), THE VALVE PASSED THE TEST. THE VALVE WAS FLUSHED AND THE VALVE PASSED THE TEST NO OCCLUSION WAS NOTED. THE SIPHON GUARD WAS TESTED. THE VALVE PASSED THE TEST. THE VALVE WAS REFLUX TESTED. THE VALVE PASSED THE TEST. THE VALVE WAS LEAK TESTED, NO LEAKS WERE FOUND. THE SIPHON GUARD WAS REMOVED. THE VALVE WAS DRIED. THE VALVE WAS THEN PRESSURE TESTED, THE VALVE PASSED THE TEST. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3162, WITH LOT CTBCVB, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK IN 19TH FEBRUARY 2015. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REP PRESENTED VERBALLY: BEFORE IMPLANTATION, SURGEON WAS UNABLE TO PRIME 823162. THEY USED A REPLACEMENT WITH NO DIFFICULTIES, DELAYING SURGERY BY SEVERAL MINUTES. SENDING VALVE IN FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192740 HAKIM INLINE PROGRAMMABLE VALVE SG SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CTBCVB

    Patients

    Seq Age Sex Outcome Treatment
    1