BEUDAMED
    FDA Adverse Event Death Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1793182 · Received August 6, 2010

    Report

    Report Number
    1222780-2010-00111
    Event Type
    Death
    Date Received
    August 6, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 9, 2010
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINT. THE DEVICE IS NOT BEING RETURNED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER. THE LOT WAS RELEASED MEETING ALL QA SPECIFICATIONS. CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP OR IMPACT TO THE REPORTED OBSERVATION. BASED ON THE INFO OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE NOVASURE SYSTEM. IF ADDITIONAL RELEVANT INFO IS RECEIVED OR WHEN THE FINAL AUTOPSY REPORT BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNEVENTFUL NOVASURE ENDOMETRIAL ABLATION WAS DONE ON (B)(6)2010. AT THE TIME OF THE PROCEDURE, THE PT HAD A "PERSISTENT COUGH [AND] WAS SHORT OF BREATH" WHICH THE PHYSICIAN ATTRIBUTED TO ANEMIA. THE PT WAS GIVEN ORAL TORADOL (KETOROLAC TROMETHAMINE), VICODIN (HYDROCODONE BITARTRATE), AND ATIVAN (LORAZEPAM) JUST PRIOR TO THE ABLATION. A PARACERVICAL BLOCK WAS ADMINISTERED CONSISTING OF 300CC OF CARBOCAINE. THE PT WAS CONSCIOUS DURING THE ENTIRE PROCEDURE AND TOLERATED THE PROCEDURE WELL. THE ABLATION LASTED 1 MINUTE AND 15 SECONDS. THE PT WAS DISCHARGED HOME, IN STABLE CONDITION, WITH HER HUSBAND, SHORTLY AFTER THE PROCEDURE. THE PHYSICIAN¿S STAFF MADE A CALL TO THE PT LATER THAT DAY AND REPORTEDLY SHE WAS DOING WELL. THE PHYSICIAN REPORTED THE PT TOOK A VICODIN (DOSE UNK) PRIOR TO GOING TO SLEEP THAT NIGHT, AROUND 10PM. HER HUSBAND WAS AWAKEN AROUND 3AM WHEN THE PT FELL FROM BED. SHE FELT COLD TO TOUCH AND HE CALLED 911. THEY INITIATED CARDIOPULMONARY RESUSCITATION AND TRANSPORTED THE PT TO THE HOSPITAL WHERE SHE WAS PRONOUNCED DEAD ON (B)(6)2010. PRELIMINARY AUTOPSY RESULTS INDICATE "THE PT DIED AS A RESULT OF PULMONARY EMBOLISM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 09K07RA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death NOT PROVIDED BY THE COMPLAINANT.| SERIAL NUMBER OF THE RADIO FREQUENCY CONTROLLER| RADIO FREQUENCY CONTROLLER - SERIAL NUMBER: UNK| BIRTH CONTROL PILLS (DATE INITIATED UNK).| MIRCETTE (ETHINYL ESTRADIOL AND DESOGESTREL)