BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2500877 · Received March 16, 2012

    Report

    Report Number
    3007069406-2012-00075
    Event Type
    Other
    Date Received
    March 16, 2012
    Date of Event
    November 19, 2008
    Report Date
    February 22, 2012
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED BASED ON A RETROSPECTIVE REVIEW OF PEAK CLINICAL STUDIES. PRODUCT WAS NOT AVAILABLE FOR EVALUATION BECAUSE THE COMPLAINT FILE WAS OPENED BASED ON THE RETROSPECTIVE REVIEW OF THE CLINICAL STUDY FILE. A LOT NUMBER WAS NOT PROVIDED SO AN INVESTIGATION OF THE LOT HISTORY RECORD COULD NOT BE PERFORMED. END OF REPORT.

    Description of Event or Problem · 1

    SUBJECT IN A PEAK RETROSPECTIVE ABDOMINOPLASTY STUDY WAS DOCUMENTED TO HAVE AN IRREGULAR HEART RATE (IN PACU WITH OXYGEN SATURATION DROP, PATIENT SENT TO EMERGENCY ROOM, ADMITTED AND DISCHARGED TWO HOURS LATER.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TISSUE DISSECTION DEVICE GEI MEDTRONIC ADVANCED ENERGY LLC PLASMABLADE 4.0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other NOT AVAILABLE