BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS INLINE VLV ONLY

    MDR report key: 2911685 · Received January 11, 2013

    Report

    Report Number
    1226348-2013-10858
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 17, 2012
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK112156
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    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

    REP REPORTED THAT BOTH CATHETERS WERE TESTED AND BOTH WERE PATENT BUT COULD NOT GET ANY FLOW THROUGH THE VALVE. EXPLANTED THE VALVE AND REPLACED IT WITH ANOTHER CERTAS VALVE. TESTED THE EXPLANTED VALVE AFTER EXPLANT WITH A MONOMETER AND IT FLOWED JUST FINE. COULD NOT FIGURE OUT WHY THE VAVLE WOULD NOT FLOW WHILE IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16594 CERTAS INLINE VLV ONLY SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention