BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 4102103 · Received September 19, 2014

    Report

    Report Number
    1226348-2014-11992
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    September 12, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    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

    (B)(4). UPON COMPLETION OF THE 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 A PROBLEM. THE LOT NUMBER IS CMNCH7, SERIAL NUMBER (B)(4), PRODUCT CODE 82-3115. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 130MMH2O.THE VALVE WAS VISUALLY INSPECTED; NO DEFECTS WERE NOTED, THE CAM POSITION HAS NOT CHANGED IN THE LAST 2 DAYS. THE VALVE WAS TESTED FOR PROGRAMMING AND THE VALVE PASSED THE TEST. THE VALVE WAS THEN PRESSURE TESTED, THE VALVE PASSED THE TEST. 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. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE, PRODUCT CODE 82-3115, WITH LOT NUMBER CMNCH7, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 14TH DECEMBER 2011. NO ROOT CAUSE COULD BE DETERMINED, AS NO PROBLEM WAS FOUND WITH THE VALVE. 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. AS NOTED IN THE IFU: WARNINGS SUBJECTING THE VALVE TO STRONG MAGNETIC FIELDS MAY CHANGE THE SETTING OF THE VALVE. THE USE OF MAGNETIC RESONANCE (MR) SYSTEMS UP TO 3 T WILL NOT DAMAGE THE VALVE MECHANISM, BUT MAY CHANGE THE SETTING OF THE VALVE. CONFIRM THE VALVE SETTING AFTER AN MRI PROCEDURE. SEE PROGRAMMING THE PROGRAMMABLE VALVE. COMMON MAGNETS GREATER THAN 80 GAUSS, SUCH AS HOUSEHOLD MAGNETS, LOUDSPEAKER MAGNETS, AND LANGUAGE LAB HEADPHONE MAGNETS, MAY AFFECT THE VALVE SETTING WHEN PLACED CLOSE TO THE VALVE. MAGNETIC FIELDS GENERATED FROM MICROWAVES, HIGH-TENSION WIRES, ELECTRIC MOTORS, TRANSFORMERS, ETC., DO NOT AFFECT THE VALVE SETTING.

    Description of Event or Problem · 1

    IMPLANTATION: (B)(6) 2012; EXPLANTATION: (B)(6) 2014; VALVE ADJUSTED BY ITSELF TWO TIMES. AS A RESULT THE DEVICE WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585264 HAKIM PROGRAMMABLE VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CMNCH7

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention