BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VPV SYSTEM

    MDR report key: 2133422 · Received June 15, 2011

    Report

    Report Number
    1226348-2011-00222
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    April 27, 2011
    Manufacturer
    CODMAN & SHURTLEFF, INC. MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE PROGRAMMER DISPLAYED AN ERROR MESSAGE. A DIFFERENT SYS WAS USED TO COMPLETE THE CASE HOWEVER THE DESIRED PRESSURE SETTING COULD NOT BE ACHIEVED. THE SETTING THAT WAS ACHIEVED WAS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VPV SYSTEM VALVE, PROGRAMMER JXG CODMAN & SHURTLEFF, INC. MEDOS S.A. NA V05934

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK