BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE W/SIPHONGUARD

    MDR report key: 3000306 · Received March 12, 2013

    Report

    Report Number
    1226348-2013-13622
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 12, 2013
    Product Code
    JXG
    PMA / PMN Number
    PK992173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THIS COMPLAINT COULD NOT BE CONFIRMED. THE DEVICE WAS VISUALLY AND FUNCTIONALLY TESTED AND WAS FOUND TO WORK IN ACCORDANCE WITH THE MANUFACTURING SPECIFICATIONS. THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. A TEAR IN THE SILICONE HOUSING AROUND THE DISTAL END OF THE SIPHON GUARD WAS NOTED, HOWEVER, THIS COULD HAVE OCCURRED DURING THE EXPLANTATION PROCEDURE, BUT THIS COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THIS DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTIONS. BASED ON THE RESULTS OF THIS INVESTIGATION, NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CLOSED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE SALES REP REPORTED A VALVE MALFUNCTION OR OCCLUSION AS THE DEVICE WAS NOT DRAINING. AS A RESULT THE DEVICE WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103331 HAKIM PROGRAMMABLE VALVE W/SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG 82-3132 955504

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention