BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2822167 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00273
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Report Date
    October 19, 2010
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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 08/15/2010 THROUGH 08/15/2012. EVALUATION: THE PULSAR GENERATOR WAS RECEIVED IN FAIR CONDITION WITH DARK SURFACE IMPERFECTIONS. HOLES HAD BEEN DRILLED ON THE REAR PANEL FOR UNK REASONS. THE UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS ACROSS ALL MODES. THE REAL TIME CLOCK WAS FOUND CORRUPTED. THE REPORTED INABILITY TO CUT/COAG COULD NOT BE DUPLICATED. THE CLOCK WAS CORRUPTED DUE TO BATTERY THAT HAD DIED PREMATURELY FOR UNK REASONS. CLEANED FILINGS FROM DRILLED HOLES AND REPLACED THE CLOCK BATTERY. 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 WAS CUT AND COAG FAULTS. THERE WAS NO PT IMPACT.

    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