BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2822157 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00284
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    November 17, 2010
    Report Date
    November 18, 2010
    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. THE UNIT BOOTED INTO A F2 FAULT ON THE LAST DAY OF USE. IF A USER PRESSES A BUTTONS DURING BOOT, THE SYSTEM FAILS THE POWER-ON SELF TEST WITH AN F2 AND REQUIRES A REBOOT. THE SYSTEM BEHAVED CORRECTLY; THERE WERE NO PROBLEMS WITH THE UNIT. REPAIRS WERE PERFORMED. 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 DURING A MASTECTOMY/RECONSTRUCTION CASE THERE WAS A FAULT. THERE WAS NO PT EFFECT.

    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