BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRG CYLIN VALVE ASD RICK

    MDR report key: 3052145 · Received April 11, 2013

    Report

    Report Number
    1226348-2013-15177
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 21, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK053350
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CODMAN HAS REQUESTED RETURN OF THE VALVE FOR EVALUATION. HISTORICALLY, FOR COMPLAINTS OF THIS NATURE, EXAMINATIONS OF THE VALVES HAVE REVEALED THE ACCUMULATIONS OF BIOLOGICAL DEBRIS WITHIN THE VALVES OR CATHETERS, WHICH HAVE RESULTED IN BLOCKAGES WITHIN THE DEVICES, RESTRICTING FLOW. REVIEWS OF THE DEVICE HISTORY RECORDS HAVE CONFIRMED THAT THE VALVES HAVE MET SPECIFICATIONS WHEN RELEASED TO STOCK. A FOLLOW UP REPORT WILL BE FILED IF THE INVESTIGATION OF THIS DEVICE REVEALS A RESULT DIFFERENT FROM THAT WHICH IS STATED ABOVE OR IF ANY FURTHER INFORMATION REGARDING THE CAUSE OR MODE OF FAILURE IS MADE AVAILABLE. OTHERWISE, THE COMPLAINT IS CLOSED AT THIS TIME.

    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

    THE SALES REP REPORTED THAT THERE WAS NO FLOW IN THE SHUNT SYSTEM. AS A RESULT, THE DEVICE WAS REVISED. PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156212 PRG CYLIN VALVE ASD RICK SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CMPBFG

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention