BEUDAMED
    FDA Adverse Event Death Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 4595206 · Received March 7, 2015

    Report

    Report Number
    1222780-2015-00036
    Event Type
    Death
    Date Received
    March 7, 2015
    Date of Event
    February 5, 2015
    Report Date
    February 5, 2015
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT AND SERIAL NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE THE EXPIRATION DATE IS NOT KNOWN. THE DEVICE IS NOT BEING RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. LOT NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE THE MANUFACTURE DATE IS NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE RADIO FREQUENCY CONTROLLER. THERE WERE NO REWORKS OR OBSERVATIONS NOTED AT TIME OF MANUFACTURE. NO RELATIONSHIP CAN BE ESTABLISHED BETWEEN DHR AND CURRENT COMPLAINT. IF ADDITIONAL RELEVANT INFO IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED TO PERFORM A NOVASURE ENDOMETRIAL ABLATION ON (B)(6) 2015. THE PHYSICIAN SEATED THE ELECTRODE ARRAY, AND RECEIVED AN UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TEST. THE DEVICE WAS REMOVED AND "THE PT ARRESTED. ALL RESUSCITATION EFFORTS WERE UNSUCCESSFUL AND THE PT EXPIRED". CURRENTLY, THE AUTOPSY REPORT IS NOT AVAILABLE. WE HAVE BEEN UNABLE TO OBTAIN ADDITIONAL INFO SURROUNDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160120 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM UTERINE ABLATION DEVICE MNB HOLOGIC NS2000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death RADIO FREQUENCY CONTROLLER: (B)(4)