BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2821403 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00322
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    May 26, 2011
    Report Date
    May 26, 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 (B)(4) 2010 THROUGH (B)(4) 2012. THE PULSAR GENERATOR WAS REC'D IN FAIR CONDITION, WITH MANY SURFACE IMPERFECTIONS ON THE LOWER CASE. THE UNIT DELIVERED RF ENERGY CORRECTLY INTO THE FIXED RESISTORS. THE F6 FAULT INDICATES A TEMPORARY LOSS OF COMMUNICATION BETWEEN THE UCB AND RF CONTROLLER. THE CABLE CONNECTING THE UCB TO RF CONTROLLER WAS REPLACED IN AN ATTEMPT TO REDUCE THE FREQUENCY OF THIS FAULT. 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 THERE WERE F6 (RF MODULE COMMUNICATION WITH THE CONTROLLER PROCESSOR HAS FAILED) AND F2 (SELF-TEST FAULT) ERROR CODES. 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