BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS INLINE VLV ONLY

    MDR report key: 2841977 · Received November 21, 2012

    Report

    Report Number
    1226348-2012-00617
    Event Type
    Injury
    Date Received
    November 21, 2012
    Manufacturer
    CODMAN AND SHURTLEFF - MEDOS
    Product Code
    JXG
    PMA / PMN Number
    K112156
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 WHICH APPEARS TO HAVE CAUSED THE DIFFICULTY ENCOUNTERED BY THE CUSTOMER. ONCE THE OCCLUSION WAS FLUSHED THE DEVICE FLOWED FREELY. 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

    REP REPORTED THAT THE VALVE WAS NOT FLOWING PROPERLY. THE VALVE REQUIRED OVER 40 CM H2O TO FLOW AT SETTING 4. THIS WAS A VALVE THAT WAS IMPLANTED 3 WEEKS PRIOR TO THE EVENT. SURGEON COULD NOT FIND AN OCCLUSION OR ANYTHING THAT WOULD REQUIRE SUCH A HIGH PRESSURE TO FLOW. SURGEON CONFIRMED THAT BOTH CATHETERS WERE PATENT AND EVENTUALLY REPLACED THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERTAS INLINE VLV ONLY SHUNT, CENTRAL NERVOUS SYSTEM COMPS JXG CODMAN AND SHURTLEFF - MEDOS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention