BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2821409 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00316
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    April 26, 2011
    Report Date
    April 27, 2011
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED BASED ON A RETROSPECTIVE REVIEW OF COMPLAINTS REC'D BY THE MFR FOR THE TIME PERIOD 08/15/2010 THROUGH 08/15/2012. THE PULSAR GENERATOR WAS REC'D IN POOR CONDITION WITH MINOR SURFACE IMPERFECTIONS. THE FRONT OVERLAY WAS SCUFFED AND SCRATCHED. THE UNIT DELIVERY ENERGY CORRECTLY INTO THE FIXED RESISTORS. THE CUT LEVEL ADJUSTMENT BUTTON COULD NOT BE ADJUSTED DOWN. THE ERROR LOG CONTAINED AN F5 (RF MODULE MONITOR HAS DETECTED A RF MODULE FAILURE) FAULT, NOT AN F6 (REASON FOR RETURN). THE F5 CODE COULD NOT BE REPLICATED. THE UNIT WAS REPAIRED AND APPLICABLE SOFTWARE AND HARDWARE UPGRADES WERE PERFORMED. THE UNIT PASSED FINAL TESTING AND WAS RECERTIFIED FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED AN F6 (RF MODULE) COMMUNICATION WITH THE CONTROLLER PROCESSOR HAS FAILED) FAULT CODE APPEARED. THERE WAS NO PT IMPACT OTHER THAN DELAY OF THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAR GENERATOR GEI MEDTRONIC ADVANCED ENERGY LLC PULSAR GENERATOR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PLASMABLADE