BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMING VALVE

    MDR report key: 3821469 · Received May 20, 2014

    Report

    Report Number
    1226348-2014-11657
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 24, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK020667
    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. DEVICE IS UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE DEVICE WAS RETURNED FOR EVALUATION. THE INVESTIGATION OF THE RETURNED DEVICE DID CONFIRM THE PROBLEM REPORTED BY THE CUSTOMER. THE LOT NUMBER IS CMMC54, SERIAL NUMBER (B)(4), PRODUCT CODE NS9009. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 30MMH2O. THE VALVE WAS VISUALLY INSPECTED; A NEEDLE HOLE IN THE NEEDLE CHAMBER WAS NOTED, NO DEFECTS WERE NOTED. THE VALVE WAS IRRIGATED WITH PURIFIED WATER. NO OCCLUSION WAS NOTED. THE CATHETERS WERE IRRIGATED WITH PURIFIED WATER. NO OCCLUSIONS WERE NOTED. THE VALVE WAS DRIED. THE VALVE WAS LEAK TESTED AND ONLY LEAKED FROM THE NEEDLE HOLE, NO OTHER LEAKS WERE NOTED. THE VALVE WAS REFLUX TESTED AND THE VALVE PASSED THE TEST. THE VALVE WAS TESTED FOR PROGRAMMING AND THE VALVE PASSED THE TEST. THE VALVE WAS THEN PRESSURE TESTED AND THE VALVE PASSED THE TEST. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. NO ROOT CAUSE COULD BE DETERMINED, AS NO PROBLEM WAS FOUND WITH THE VALVE. 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 DEVICE WAS IMPLANTED VIA L-P SHUNT TO THE PATIENT WHO IS (B)(6) MALE IN (B)(6) 2012. (THIS WAS THE REPLACEMENT SURGERY OF THE VALVE THAT WAS IMPLANTED VIA V-P SHUNT IN (B)(6) 2010, CAUSING CEREBRAL MENINGITIS.) THE PATIENT CAME TO THE HOSPITAL DUE TO HIS HEADACHE. THE PATIENT'S CONDITION WAS NOT IMPROVED EVEN AFTER THE DEVICE WAS PUMPED UP SOMETIMES. THE REVISION SURGERY WAS CONDUCTED ON (B)(6) 2014 SINCE THE SURGEON SUSPECTED THE OCCLUSION OF THE DEVICE. THE SETTING PRESSURE OF THE REMOVED VALVE WAS UNKNOWN. THE KIND AND THE SETTING PRESSURE OF THE REPLACED VALVE ARE NOT INFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300447 HAKIM PROGRAMMING VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF CMMC54

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention