BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2821350 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00350
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Report Date
    November 9, 2011
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED BASED ON A RETROSPECTIVE REVIEW OF COMPLAINTS RECEIVED BY THE MANUFACTURER FOR THE TIME PERIOD (B)(4) 2010 THROUGH (B)(4) 2012. THE PULSAR GENERATOR WAS RECEIVED IN FAIR CONDITION, WITH MINOR SURFACE IMPERFECTIONS. THE UNIT DELIVERED RF ENERGY CORRECTLY INTO THE FIXED RESISTORS. THERE WERE NO PROBLEMS FOUND. THE UNIT WAS POWERED UP ON ONE UNIQUE DAY IN THE FIELD. THE ERROR LOG DOES NOT CONTAIN ANY ENTRIES OTHER THAN THE FACT THAT IT WAS POWERED UP ON THE SAME DAY THAT IT ARRIVED IN THE FIELD. THE UNIT PASSED FINAL TESTING AND WAS RECERTIFIED FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE EXCESSIVE GROUND PAD ERRORS; AT LEAST ONE TIME PER CASE. THERE WAS NO PATIENT IMPACT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PLASMABLADE