BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM VALVE

    MDR report key: 2760847 · Received September 26, 2012

    Report

    Report Number
    1226348-2012-00476
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    August 14, 2012
    Manufacturer
    CODMAN AND SHURTLEFF - MEDOS
    Product Code
    JXG
    PMA / PMN Number
    K974739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, JA
    Reporter Occupation
    OTHER

    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 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.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE PATIENT DEVELOPED ENLARGED VENTRICLES. A BLOCKAGE OF THE VALVE WAS SUSPECTED. AS A RESULT THE DEVICE WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM VALVE SHUNT, CENTRAL NERVOUS SYSTEM COMPS JXG CODMAN AND SHURTLEFF - MEDOS CMBC3V

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention