BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS INLINE VLV

    MDR report key: 6456375 · Received April 4, 2017

    Report

    Report Number
    1226348-2017-10229
    Event Type
    Injury
    Date Received
    April 4, 2017
    Date of Event
    March 9, 2017
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K112156
    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, IT WAS NOTED THAT THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS AT SETTING 5. THE VALVE WAS VISUALLY INSPECTED: NO DEFECTS WERE NOTED. THE VALVE WAS HYDRATED. THE VALVE WAS TESTED FOR PROGRAMMING. 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 WERE NOTED. THE VALVE WAS REFLUX TESTED. THE VALVE PASSED THE TEST. THE VALVE WAS DRIED. THE VALVE WAS THEN PRESSURE TESTED, THE VALVE PASSED THE TEST. REVIEW OF THE HISTORY DEVICE RECORDS FOR THE CERTAS VALVE, PRODUCT CODE 82-8801 WITH LOT CTBB4LR, SHOWED 2 NR AND 1 NC REPORT WHEN RELEASED TO STOCK ON THE 1ST OCTOBER 2015, THE NR¿S AND NC REPORT ISSUES HAD NO LINK TO THIS COMPLAINT. 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

    THE VALVE PROGRAMMER SHOW A VALUE (EX:2) AND WHEN THE SURGEON MADE THE RADIOLOGICAL TEST TO CONFIRM, IT SHOWS A DIFFERENT VALUE. IT HAPPENS EVERY TIME THE SURGEON MADE THIS CONFIRMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238521 CERTAS INLINE VLV SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CTBB4L-R

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention