BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 3906418 · Received July 1, 2014

    Report

    Report Number
    1226348-2014-11788
    Event Type
    Injury
    Date Received
    July 1, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    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

    THE DEVICE WAS RETURNED FOR EVALUATION. THE INVESTIGATION OF THE RETURNED DEVICE DID NOT CONFIRM THE PROBLEM REPORTED BY THE CUSTOMER. THE LOT NUMBER IS 1083473, SERIAL NUMBER (B)(4), PRODUCT CODE 82-3100. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 30MMH2O. THE VALVE WAS VISUALLY INSPECTED; NEEDLE HOLES IN THE SILICONE HOUSING WERE NOTED IN BETWEEN THE TITANIUM NEEDLE STOP AND THE VALVE MECHANISM CASING. THE VALVE WAS IRRIGATED WITH PURIFIED WATER. NO OCCLUSION WAS NOTED. THE CATHETERS WERE IRRIGATED WITH PURIFIED WATER, NO OCCLUSION WAS NOTED. THE VALVE WAS DRIED. THE VALVE WAS LEAK TESTED; THE VALVE LEAKED FROM THE NEEDLE HOLES, NO OTHER LEAKS WERE NOTED. THE VALVE WAS REFLUX TESTED, THE VALVE PASSED THE TEST. THE VALVE WAS TESTED FOR PROGRAMMING; THE VALVE PASSED THE TEST. THE VALVE WAS THEN PRESSURE TESTED, THE VALVE PASSED THE TEST. THE LOT HISTORY RECORD WAS REVIEWED FOR COMPLETENESS DURING THE RELEASE PROCESS TO INVENTORY. AT THAT TIME BASED ON THE FACT THAT NO DISCREPANCIES WERE NOTED FOR THE PRODUCTS BEING ACCEPTED, THEY WERE RELEASED TO STOCK ON THE (B)(6) 2003. NO ROOT CAUSE COULD BE DETERMINED, AS THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE DEVICE WAS ORIGINALLY IMPLANTED VIA V-P SHUNT TO THE PATIENT SEVERAL YEARS AGO. IT WAS FOUND THAT THE VENTRICLES OF THE PATIENT'S BRAIN BECAME LARGE, AND THE PRESSURE WAS CHANGED TO 30MMH2O. BUT THE VENTRICULAR ENLARGEMENT WAS STILL OBSERVED. THE SURGEON SUSPECTED THE BLOCKAGE OF THE VALVE AND EXAMINED THE CSF BY EXTRACTING IT FROM THE CHAMBER AND THE VALVE AND PERITONEAL CATHETER WERE CONSIDERED TO BE OCCLUDED. ALSO, THE SHUNT INFECTION WAS CONFIRMED AND THE REVISION SURGERY WAS CONDUCTED. THERE IS NO INFORMATION WITH REGARDS TO THE TYPE OF REPLACED VALVE AND ITS PRESSURE SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383662 HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF 1083473

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention