BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM INLINE PROGRAMMABLE VALVE SG

    MDR report key: 4193619 · Received October 22, 2014

    Report

    Report Number
    1226348-2014-12067
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    August 30, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    JXG
    PMA / PMN Number
    PK992173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 150MMH2O. THE VALVE WAS VISUALLY INSPECTED: NO DEFECTS WERE NOTED. THE VALVE WAS IRRIGATED WITH PURIFIED WATER. NO OCCLUSION WAS NOTED. THE SIPHON GUARD 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 TESTED FOR PROGRAMMING. THE VALVE PASSED THE TEST. THE SIPHON GUARD WAS REMOVED FOR THE PRESSURE TEST. THE VALVE WAS THEN PRESSURE TESTED, THE VALVE PASSED THE TEST. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE, PRODUCT CODE 82-3162, WITH LOT NUMBER CRGCCD, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 19TH JUNE 2014. NO ROOT CAUSE COULD BE DETERMINED AS NO PROBLEM WAS FOUND WITH THE VALVES. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    SALES REP. DOESN'T HAVE ANY DETAILS AT THIS TIME. HE IS WAITING TO GET MORE INFORMATION FROM THE DOCTOR REGARDING THE DETAILS OF THE PROBLEM. ON 10/22/2014, THE REP HAS MADE A COUPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THIS COMPLAINT. HE HAS COMMUNICATED THAT THE HOSPITAL HAS NOT BEEN RESPONSIVE. AS A RESULT THE COMPLAINT WILL BE FILED AS IT APPEARS AN EXPLANT OCCURRED ON (B)(6) 2014. IT IS UNKNOWN IF THIS WAS INTRA-OPERATIVE OR WHAT THE INITIAL IMPLANT DATE OF THE DEVICE IS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671438 HAKIM INLINE PROGRAMMABLE VALVE SG SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC CRGCCD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention