BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEAK PULSAR GENERATOR

    MDR report key: 2800081 · Received October 17, 2012

    Report

    Report Number
    3007069406-2012-00233
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 17, 2012
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT WHEN USING TWO PEAK GENERATORS SIMULTANEOUSLY ON ONE PT, POWER ALMOST IMMEDIATELY DECREASED TO A VERY LOW LEVEL. THE UNIT IS BEING RETURNED TO THE MFR FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN USING TWO PEAK GENERATORS SIMULTANEOUSLY ON ONE PT, POWER ALMOST IMMEDIATELY DECREASED TO A VERY LOW LEVEL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1