BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM INLINE PROGRAMMABLE VALVE SG

    MDR report key: 2882001 · Received December 20, 2012

    Report

    Report Number
    1226348-2012-00628
    Event Type
    Injury
    Date Received
    December 20, 2012
    Manufacturer
    CODMAN AND SHURTLEFF - MEDOS
    Product Code
    JXG
    PMA / PMN Number
    K992173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE VALVE REVEALED THE PRESENCE OF BIOLOGICAL DEBRIS WITHIN THE DEVICE. THIS BIOLOGICAL DEBRIS CAUSED AN OCCLUSION IN THE DEVICE AND FOR THE RETURNED VALVE THE PRESSURE TEST, WHICH APPEARS TO HAVE CAUSED THE DIFFICULTY ENCOUNTERED BY THE CUSTOMER. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE VALVE MET SPECIFICATION REQUIREMENTS WHEN RELEASED TO STOCK. 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

    AFTER IMPLANTATION, MALFUNCTION OF THE VALVE WAS NOTED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY. NO FURTHER INFORMATION INCLUDING DOI AND DOR IS AVAILABLE AT THIS MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM INLINE PROGRAMMABLE VALVE SG SHUNT, CENTRAL NERVOUS SYSTEM COMPS JXG CODMAN AND SHURTLEFF - MEDOS PRE470

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention