BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 3841468 · Received May 30, 2014

    Report

    Report Number
    1226348-2014-11681
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    April 24, 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

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

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 100MMH2O. THE VALVE WAS VISUALLY INSPECTED AND NO DEFECTS WERE NOTED. THE VALVE WAS TESTED FOR PROGRAMMING AND PASSED THE TEST. THE VALVE WAS THEN PRESSURE TESTED AND PASSED THE TEST. THE VALVE WAS IRRIGATED WITH PURIFIED WATER AND NO OCCLUSION WAS NOTED. THE VALVE WAS DRIED AND LEAK TESTED, NO LEAKS WERE NOTED. THE VALVE WAS REFLUX TESTED AND 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 THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    IT WASN´T POSSIBLE TO ADJUST THE SHUNT VALVE. THE VALVE WAS REPLACED 2014-(B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318292 HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF CPBBWF

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention