BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE MICRO VALVE

    MDR report key: 6960596 · Received October 18, 2017

    Report

    Report Number
    1226348-2017-10776
    Event Type
    Injury
    Date Received
    October 18, 2017
    Date of Event
    September 28, 2017
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K980778
    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

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 140 MMH2O. THE VALVE WAS VISUALLY INSPECTED; NO ISSUES WERE OBSERVED. THE VALVE WAS TESTED FOR PROGRAMMING AND FAILED; THE CAM MECHANISM DID NOT MOVE DURING THE PROGRAMMING PROCESS. THE VALVE WAS FLUSHED, NO OCCLUSION WAS NOTED. A LEAK TEST WAS PERFORMED AND PASSED. A REFLUX WAS PERFORMED AND PASSED. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: BIOLOGICAL DEBRIS WAS FOUND ON THE SPRING, ON THE SPRING PILLAR, THE CAM MECHANISM, AND ON THE BASE PLATE. THE MAGNETS WERE CONTROLLED AND PASSED TESTING. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3112, WITH LOT CVGBGC CONFORMED TO SPECIFICATIONS WHEN RELEASED TO STOCK. THE ROOT CAUSE OF THE PROGRAMMING PROBLEM WAS DUE TO THE BIOLOGICAL DEBRIS FOUND THE VALVE ROTOR AND STATOR. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 1

    (B)(4). THE VALVE STOPPED TO WORK PROBABLY DUE TO A BLOCK OF THE KNOB. IT WAS REPLACED. REVISION SURGERY WAS NECESSARY+ ANTIBIOTIC THERAPY. PATIENT GENDER: M. THERE WAS NO REPORT OF INFECTION TO CAUSE THE USE OF ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739091 HAKIM PROGRAMMABLE MICRO VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CVGBGC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention