BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN VPV SYSTEM

    MDR report key: 2194904 · Received July 13, 2011

    Report

    Report Number
    1226348-2011-00269
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    K061876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, IT WAS FOUND THAT THE TWO VPV'S PROGRAMMERS P/N 82-3192; (B)(4) WERE FOUND FULLY FUNCTIONAL. THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED. BOTH VPV'S RESET A VALVE AND CONFIRM THE SETTINGS, AT DIFFERENT SETTINGS, WITHOUT ANY DIFFICULTIES. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    REP REPORTED THAT THE DEVICE REPROGRAMMED ITSELF. IT WAS ALSO NOTED THAT THE PT HAS USED SPECIAL HANDSETS RECENTLY THAT MAY HAVE RESET THE VALVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK