BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 3092357 · Received April 29, 2013

    Report

    Report Number
    1222780-2013-00076
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 20, 2013
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE IDENTIFIED LOT NUMBER AND SERIAL NUMBER OF THE DISPOSABLE DEVICE. NO ABNORMALITIES WERE FOUND RELATED TO THE REPORTED INFO. THIS DEVICE PASSED FINAL TESTING PRIOR TO RELEASE. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013, A PT'S PRE-ABLATION WORK UP WAS UNREMARKABLE. THE PHYSICIAN THEN ATTEMPTED A NOVASURE ENDOMETRIAL ABLATION. WHEN HE INSERTED THE DISPOSABLE DEVICE AND THE PT EXPERIENCED "2 TO 3 SEIZURES OVER A 45 MINUTE PERIOD". THE PROCEDURE WAS ABORTED. NO INTERVENTION WAS REQUIRED. THE PT WAS DISCHARGED HOME. ON (B)(6) 2013, IT WAS REPORTED THE PT IS DOING. "THE PT HAS SEEN A NEUROLOGIST AND ANOTHER SPECIALIST (TYPE UNK) AND HER TEST ASSESSMENTS CAME BACK UNREMARKABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184280 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 12L07RD

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other RADIO FREQUENCY CONTROLLER: SERIAL NUMBER, UNK