BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2821385 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00329
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Report Date
    June 24, 2011
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 MFR FOR THE TIME PERIOD (B)(4) 2010 THROUGH (B)(4) 2012. THE PULSAR GENERATOR WAS RECEIVED IN POOR CONDITION WITH SCUFFS AND SCRATCHES ON THE UPPER CASE AND FRONT PANEL OVERLAY. THE UNIT POWERED-UP ONCE INTO A WHITE/BLANK DISPLAY SCREEN, INDICATING THAT THE UCB STILL NEEDED A JUMPER BETWEEN NTRST AND GROUND. WHEN THE UNIT POWERED UP BOTH PEAK CUT AND REGULAR CUT OUTPUT ENERGY WERE DISTORTED. THE RF CONTROLLER CONNECTOR TO THE RF AMPLIFIER WAS INTERMITTENT. AFTER THE RF CONTROLLER WAS REPAIRED, THE UNIT DELIVERED RF ENERGY CORRECTLY INTO THE FIXED RESISTORS. THE COMPLAINT WAS CAUSED BY AN INTERMITTENT J7 CONNECTOR ON THE RF CONTROLLER PCBA. THIS CONNECTOR CARRIES ALL DRIVE SIGNALS FOR OUTPUT WAVEFORMS. CONSTANT FORCE WAS APPLIED TO THIS CONNECTOR CAUSED BY EARLY PC BOARD HOLES NOT ALIGNING EXACTLY WITH THE MOUNTING HOLES. STRESS CAUSED THE CONNECTOR PINS TO EVENTUALLY PULL AWAY FROM THE PCBA AND YIELD AN OPEN CONNECTION. THE RF CONTROLLER WILL HAVE MOUNTING HOLES SLOTTED TO CORRECT PCB ALIGNMENT. THE UNIT WAS REPAIRED. APPLICABLE SOFTWARE AND HARDWARE UPGRADES WERE PERFORMED. THE UNIT PASSED FINAL TESTING AND WAS RECERTIFIED FOR USE. END OF REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE GENERATOR SPONTANEOUSLY STOPPED WORKING IN THE MIDDLE OF A CASE. THERE WAS NO PT INJURY.

    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