BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1972215 · Received January 19, 2011

    Report

    Report Number
    1222780-2011-00013
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 2010
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISPOSABLE DEVICE IS NOT BEING RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. THE RADIO FREQUENCY CONTROLLER HAS RETURNED AND AN ANALYSIS HAS BEEN COMPLETED. THE MANUFACTURE DATE OF THE RADIO FREQUENCY CONTROLLER IS 04/2010. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR BOTH THE DISPOSABLE DEVICE AND RFC. NO ABNORMALITIES WERE NOTED. CURRENTLY, UNABLE TO ESTABLISH A RELATIONSHIP OR IMPACT TO THE REPORTED OBSERVATION. (B)(4).

    Description of Event or Problem · 1

    DURING SOUNDING OF THE UTERINE CAVITY WITH A NON HOLOGIC DEVICE IN PREPARATION FOR A NOVASURE ENDOMETRIAL ABLATION, THE PT EXPERIENCED BRADYCARDIA (RATE UNK). THE PT THEN WENT INTO CARDIAC ASYSTOLE AT THE BEGINNING OF THE RF ABLATION CYCLE. ABLATION WAS STOPPED, THE DISPOSABLE DEVICE WAS REMOVED, AND CPR (CARDIAC PULMONARY RESUSCITATION) WAS DONE FOR 2 MINUTES. ADDITIONALLY, ATROPINE (DOSE UNK) WAS ADMINISTERED. THE PT REMAINED IN THE HOSPITAL OVERNIGHT FOR OBSERVATION. WHILE THERE SHE DEVELOPED A "LOW GRADE FEVER" (DEGREE UNK) AND ANTIBIOTICS (MEDICATION UNK) WERE GIVEN. SHE WAS DISCHARGED HOME ON (B)(6) 2010. ON (B)(6) 2011, THE PHYSICIAN REPORTED THE PT IS "DOING WELL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 10K01RA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R RADIO FREQUENCY CONTROLLER| (B)(4)