BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 2760051 · Received March 23, 2007

    Report

    Report Number
    3003407659-2007-00011
    Event Type
    Injury
    Date Received
    March 23, 2007
    Date of Event
    March 2, 2007
    Report Date
    March 21, 2007
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    USER FACILITY REPORTED PATIENT EXPERIENCED VASOVAGAL REACTION. APPROXIMATELY 1 MINUTE INTO THE ABLATION, THE PATIENT HAD A CARDIAC ARREST AND THEN NORMAL CARDIAC ACTIVITY WITHIN 15 SECONDS. A SECOND EPISODE OCCURRED AND INTERVENTION WAS PERFORMED SUCCESSFULLY TO ESTABLISH CARDIAC ACTIVITY. PATIENT WAS HOSPITALIZED AND EVENTUALLY DISCHARGED. PATIENT IS CURRENTLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM RADIO FREQUENCY ENDOMETRIAL ABLATION MNB CYTYC SURGICAL PRODUCTS NS2000 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening