BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VPV SYSTEM

    MDR report key: 2838465 · Received November 19, 2012

    Report

    Report Number
    1226348-2012-00581
    Event Type
    Injury
    Date Received
    November 19, 2012
    Manufacturer
    CODMAN AND SHURTLEFF - MEDOS
    Product Code
    JXG
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE PROGRAMMER WAS FOUND TO BE FULLY FUNCTIONAL. THE DEVICE PROGRAMMED AT VARIOUS PRESSURE SETTINGS WITHOUT ANY DIFFICULTIES. 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 DISTRIBUTION. 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

    K061876 AND K050739. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    REP REPORTED THAT A PATIENT WAS PROGRAMMED USING A CODMAN PROGRAMMER AND THE UNIT GAVE A PROGRAM COMPLETE MESSAGE. PATIENT WAS SENT HOME AND RETURNED THE NEXT DAY. PATIENT WAS X-RAYED AND IT WAS DETERMINED THAT THE VALVE HAD NOT MOVED. A NEW PROGRAMMER WAS USED TO PROGRAM THE PATIENT. AN X-RAY CONFIRMED THE VALVE SETTING WAS PROGRAMMED TO THE DESIRED SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VPV SYSTEM VALVE PROGRAMMER JXG CODMAN AND SHURTLEFF - MEDOS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention