BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    100MM MONOP NITINOL ELECTRODE

    MDR report key: 2082539 · Received April 28, 2011

    Report

    Report Number
    3007582679-2011-00018
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 4, 2011
    Manufacturer
    STRYKER NAVIGATION
    Product Code
    GXI
    PMA / PMN Number
    K032406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AND AN INVESTIGATION IS ANTICIPATED. THIS REPORT WILL BE UPDATED IF THE INVESTIGATION REQUIRES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ERROR MESSAGE OCCURRED DURING AN RF PROCEDURE. THE CASE WAS COMPLETED WITH A BACK UP UNIT, BUT A DELAY OF 30 MINUTES OCCURRED DUE TO TROUBLESHOOTING EFFORTS. NO MEDICAL INTERVENTION WAS REQUIRED AND NO ADVERSE CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 100MM MONOP NITINOL ELECTRODE GXI STRYKER NAVIGATION 20477

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK