BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGRAMMABLE VALVE IN-LINE W/ SIPHONGUARD

    MDR report key: 3901120 · Received June 30, 2014

    Report

    Report Number
    1226348-2014-11783
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 30, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK992173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE VALVE WAS RETURNED FOR EVALUATION TO CODMAN (B)(4). THE INVESTIGATION OF THE RETURNED VALVE DID CONFIRM THE PROBLEM REPORTED BY THE CUSTOMER. THE LOT NUMBER WAS CPHBKZ, SERIAL NUMBER (B)(4), PRODUCT CODE 82-3832. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 180MMH2O. THE VALVE WAS VISUALLY INSPECTED; NO DEFECTS WERE NOTED. 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; AN OCCLUSION WAS NOTED AT THE INLET OF THE RUBY BALL. THEREFORE A FINE NEEDLE WAS INSERTED INTO THE FLOW OPENING OF THE VALVE INLET UNDER THE RUBY BALL AND ITS SEAT, THE RUBY BALL WAS MANUALLY POPPED FREE FROM ITS STUCK POSITION USING LIGHT FORCE. THE VALVE WAS IRRIGATED AGAIN, NO OCCLUSION WAS NOTED. THE SIPHON GUARD WAS IRRIGATED, 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. THE VALVE WAS RETESTED FOR PROGRAMMING; THE VALVE PASSED THE TEST. THE VALVE WAS THEN PRESSURE TESTED, THE VALVE PASSED THE TEST. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: BIOLOGICAL DEBRIS WAS FOUND ON THE SPRING, ON THE SPRING PILLAR, ON THE RUBY BALL, ON THE SEAT OF THE RUBY BALL, 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 82-3832 WITH LOT NUMBER CPHBKZ, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 1ST OCTOBER 2013. THE ROOT CAUSE OF THE PROBLEM REPORTED BY THE CUSTOMER IS DUE TO BIOLOGICAL DEBRIS FOUND ON THE SPRING, ON THE SPRING PILLAR, ON THE RUBY BALL, ON THE SEAT OF THE RUBY BALL, ON THE CAM MECHANISM, ON THE CAM MECHANISM PILLAR, AND ON THE BASE PLATE. 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.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED: AN IMPLANT SOFT DVP WITH ANTI-SIPHON AT DATE (B)(6) 2014. SUBSEQUENTLY IN REVIEWS IN CONSULTATION THE PATIENT PERSISTED WITH SYMPTOMS OF UNINTENDED INCREASE IN DRAINAGE (SINCE (B)(6) 2014) BY WHICH CHANGES TO PROGRAMMING WERE MADE. CONTINUING WITH SYMPTOMS A RE-PROGRAMATION WAS MADE, AND RADIOGRAPHIC CONTROL OF THE VALVE SHOWS THAT IT IS NOT THE PRIOR PROGRAMMED PRESSURE (THIS WAS FOUND (B)(6) 2014). AN X-RAY REVIEW WAS MADE AGAIN IN SEVERAL ATTEMPTS TO VERIFY THAT THE DESIRED PRESSURE COULDN¿T BE SET. AGAIN IN X-RAY ROOM ((B)(6) 2014) PRESSURE CHANGES AND CONTROL ARE MADE. AT THE TIME OF CONTROL WITH ANOTHER NOT IMPLEMENTED EXTERNAL VALVE WATCHING THE FAILURE IN THE PATIENT AND THE PROPER FUNCTION OF THE EXTERNAL VALVE. THEREFORE, DECIDE TO CHANGE THE VALVE. IN TAC CONTROL THE PATIENT ALWAYS SAID UNINTENDED INCREASE IN DRAINAGE OF THE VENTRICULAR SYSTEM. (B)(6) 2014 THE PRODUCT CODE WAS REPORTED AS 323832, IT IS BELIEVED THAT THE PRODUCT CODE IS 82-3832.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379332 PROGRAMMABLE VALVE IN-LINE W/ SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF CPHBKZ

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention