BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE W/PRECHAMBER

    MDR report key: 3900266 · Received June 27, 2014

    Report

    Report Number
    1226348-2014-11778
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 20, 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 CPMBPR SERIAL NUMBER (B)(4), PRODUCT CODE 82-3110. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 130MMH2O. THE VALVE WAS VISUALLY INSPECTED; NO DEFECTS WERE NOTED. 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; NO 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. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE, PRODUCT CODE 82-3110 WITH LOT NUMBER CPMBPR, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 12TH NOVEMBER 2013. 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

    DURING THE SHUNT SURGERY, THE PRESSURE SETTING OF THE SHUNT DIDN'T WORK WITH CODMAN HAKIM PROGRAMMER(82-3190), SO THE SHUNT HAS BEEN REPLACED WITH A NEW ONE IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376647 HAKIM PROGRAMMABLE VALVE W/PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF CPMBPR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention