BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2821287 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00379
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    July 24, 2012
    Report Date
    August 14, 2012
    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 MANUFACTURER FOR THE TIME PERIOD (B)(4) 2010 THROUGH (B)(4) 2012. AS OF (B)(4) 2012, THE GENERATOR HAS NOT BEEN RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED FOLLOWING DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING SURGERY, THERE WERE REPEATED E8 (OVERCURRENT) ERRORS. THE CUSTOMER TRIED ALL THE NORMAL STEPS OUTLINED IN THE USER MANUAL AND STILL GOT THE ERRORS. THEY USED A BOVIE KNIFE WHICH WAS AVAILABLE. THERE WAS NO PATIENT IMPACT.

    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