BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2821384 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00330
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Report Date
    June 27, 2011
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 08/15/2010 TO 08/15/2012. THE PULSAR GENERATOR WAS NOT RETURNED FOR EVAL. END OF REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED CUT AND COAG WERE WEAK AT A SETTING OF 8. 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