BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS INLIN VLV SPHN/UNIT CAT

    MDR report key: 3052144 · Received April 11, 2013

    Report

    Report Number
    1226348-2013-15178
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 15, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK112156
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 COULD NOT BE CONDUCTED AS THE LOT/SERIAL NUMBER HAS NOT BEEN PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    HISTORICALLY, FOR COMPLAINTS OF THIS NATURE, EXAMINATIONS OF THE VALVES HAVE REVEALED THE PRESENCE OF BIOLOGICAL DEBRIS WITHIN THE DEVICES WHICH HAVE INTERFERED WITH THEIR PROGRAMMING AND/OR PRESSURE CONTROL MECHANISMS. THE BIOLOGICAL DEBRIS HAS CAUSED THE RETURNED VALVES TO FAIL THE PROGRAMMING AND/OR PRESSURE TESTS AND APPEARS TO HAVE CAUSED THE DIFFICULTIES EXPERIENCED BY THE CUSTOMERS. 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 CONSIDERED TO BE CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT THE VALVE WAS NO LONGER ADJUSTABLE. AS A RESULT, THE DEVICE WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155198 CERTAS INLIN VLV SPHN/UNIT CAT SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention