BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 4821666 · Received June 5, 2015

    Report

    Report Number
    1226348-2015-10326
    Event Type
    Injury
    Date Received
    June 5, 2015
    Date of Event
    April 14, 2015
    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 IT WAS NOTED THAT THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 30MMH2O. THE VALVE WAS VISUALLY INSPECTED: A SMALL TEAR/CUT WAS FOUND IN THE UNDERSIDE OF THE SILICONE HOUSING. THE VALVE WAS TESTED FOR PROGRAMMING. THE VALVE FAILED THE TEST, DURING THE PROGRAMMING PROCESS THE CAM MECHANISM DID NOT MOVE. 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, LEAKED FROM THE SMALL TEAR/CUT IN SILICONE HOUSING. THE VALVE WAS REFLUX TESTED, THE VALVE PASSED THE TEST. THE VALVE WAS RETESTED FOR PROGRAMMING. THE VALVE PASSED THE TEST. THE VALVE WAS THEN PRESSURE TESTED ACCORDING TO TEST METHOD, THE VALVE PASSED THE TEST. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: BIOLOGICAL DEBRIS WAS FOUND ON THE ON THE SPRING, ON THE CAM MECHANISM, ON THE CAM MECHANISM PILLAR, AND ON THE BASE PLATE. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3115, WITH LOT CRGB4J, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 1ST JULY 2014. THE ROOT CAUSES OF THE PROGRAMMING PROBLEM IS DUE TO BIOLOGICAL DEBRIS, THIS WAS FOUND ON THE ON THE SPRING, ON THE CAM MECHANISM, THE CAM MECHANISM PILLAR, AND ON THE BASE PLATE. THE ROOT CAUSE FOR THE SMALL TEAR/CUT FOUND IN THE SILICONE HOUSING COULD BE DUE TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE SILICONE HOUSING, AS NOTED IN THE IFU SILICONE HAS A LOW CUT / TEAR RESISTANCE, THIS HOWEVER COULD NOT BE DETERMINED. 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 WAS PROGRAMMED TO 80 BEFORE IMPLANTATION. AFTER THE SURGERY THE SURGEON PROGRAMMED IT TO 100, AT THE SECOND ADAPTATION OF THE OPENING PRESSURE THE VALVE GOT STUCK AT 30. IT HAD TO BE REPLACED - WITH A SECOND SURGERY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364724 HAKIM PROGRAMMABLE VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CRGB4J

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention