BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2822370 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00180
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    July 31, 2012
    Report Date
    July 31, 2012
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 NOT RETURNED FOR EVAL. REVIEW OF THE LOT HISTORY RECORD REVEALED NO ANOMALIES. END OF REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A SIGNIFICANT REDUCTION IN POWER ON THE CUT SETTING WITH A CHANGE IN TONE PRODUCED IN THE MIDDLE OF A DEMO. INCREASING THE CUT SETTING TO 7 HAD NO EFFECT. CYCLING CORRECTED THE PROBLEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PLASMABLADE