BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN VPV SYSTEM

    MDR report key: 4220795 · Received November 3, 2014

    Report

    Report Number
    1226348-2014-12076
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 27, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    JXG
    PMA / PMN Number
    PK061876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE EXAMINATION OF THE RETURNED VPV PROGRAMMER DID NOT CONFIRM THE PROBLEM REPORTED BY THE CUSTOMER. THE PROGRAMMER WAS PLUGGED IN AND DISPLAYED ¿IMPLANTED VALVE PLEASE SELECT PRESSURE¿. THE PROGRAMMER WAS RESET ACCORDING PROCEDURE. DIFFERENT TESTS WERE PERFORMED IN ACCORDANCE WITH OUR INTERNAL TEST METHOD. THE FUNCTIONALITY OF THE PRODUCT WAS VERIFIED. 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

    (B)(4). THE 510K K061876 & K050739. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    E-MAIL RECEIVED FROM THE SALES REP. INFORMED THAT: "VPV - DIFFICULT GIVING CONFIRMATION OF SETTINGS. X-RAYS WERE OBTAINED AS CONFIRMATION". ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP. ON (B)(4) 201414, INFORMED THAT: "VPV ¿ DIFFICULT GIVING CONFIRMATION OF SETTINGS. PROGRAMMING FUNCTION WORKING PROPERLY SO NO PATIENT WAS PROGRAMMED ERRONEOUSLY. AS A RESULT- NO PATIENT INCIDENT TO REPORT. THE INABILITY TO CONFIRM CAUSES THE CLINICIAN TO TAKE AN EXTRA STEP IN OBTAINING AN X-RAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701904 CODMAN VPV SYSTEM VALVE PROGRAMMER JXG CODMAN & SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1