BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 4243320 · Received November 11, 2014

    Report

    Report Number
    1226348-2014-12093
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    November 6, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    JXG
    PMA / PMN Number
    PK980778
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT UPON A VISUAL INSPECTION, IT APPEARS THAT THE DEVICE WAS CUT. IT MIGHT ALSO BE POSSIBLE THAT IT MAY HAVE OCCURRED DURING REMOVAL AS IT WAS NOTED THAT THE DEVICE WAS INTACT WHILE IN THE PATIENT. THE VALVE AND RICHAM WERE IRRIGATED WITH PURIFIED WATER AND NO OCCLUSION WAS NOTED. THE VALVE WAS THEN DRIED AND LEAK TESTED, AND NO LEAKS WERE NOTED. THE VALVE PASSED A REFLUX TEST. THE VALVE WAS TESTED FOR PROGRAMMING. THE VALVE PASSED THE TEST. LASTLY, THE VALVE WAS PRESSURE TESTED AND THE VALVE PASSED THE TEST. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3113 WITH LOT CLDBZ1, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 9TH APRIL 2010. 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 REPORTED IN A PHONE CALL THAT THE VALVE WAS EXPLANTED AS THE SURGEON DID NOT BELIEVE IT WAS OPERATING AS IT SHOULD HAVE. THE PATIENT'S VENTRICLES WERE SMALL EVEN AFTER IT WAS SET AT 200MM H2O. ADDITIONALLY, THE DEVICE IS CURRENTLY DETACHED FROM THE RICKHAM, HOWEVER IT WAS REPORTED THAT THE DEVICE WAS INTACT WHILE IT WAS IMPLANTED. THE PATIENT RECEIVED THE INITIAL IMPLANT AT ANOTHER HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726035 HAKIM PROGRAMMABLE VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC CLDBZ1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention