BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1132135 · Received August 22, 2008

    Report

    Report Number
    1222780-2008-00091
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 24, 2008
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE RADIO FREQUENCY CONTROLLER. CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP OR IMPACT TO THE REPORTED OBSERVATION. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE DISPOSABLE DEVICE, LOT NUMBER 08C15HA. THE LOT WAS RELEASED MEETING ALL QA SPECIFICATIONS. CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP OR IMPACT TO THE REPORTED OBSERVATION. THIS DISPOSABLE DEVICE IS NOT AVAILABLE FOR EVALUATION. THESE EVALUATION CODES REFLECT THE RESULTS OF THE INVESTIGATION OF THE RADIO FREQUENCY CONTROLLER. BASED ON THE INFORMATION OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE NOVASURE SYSTEM.

    Description of Event or Problem · 1

    USER FACILITY REPORTED "UPON INITIATION OF RF [RADIO FREQUENCY] ENERGY PATIENT EXPERIENCED BRADYCARDIA". THE NOVASURE (NS) PROCEDURE WAS TERMINATED AND "THE PATIENT IMMEDIATELY STABILIZED". ON 07/28/2008, WE RECEIVED ADDITIONAL INFORMATION. IT WAS REPORTED THAT DURING THE NS PROCEDURE ON FOUR DAYS EARLIER, THE PHYSICIAN ATTEMPTED THE ABLATION A SECOND TIME AND "ABORTED WHEN THEY SAW THE PATIENT'S PULSE BEGIN TO DROP". ADDITIONALLY, IT WAS REPORTED THE PATIENT "HAD NO CARDIAC HISTORY (AND NO PACEMAKER)". AN EKG (ELECTROCARDIOGRAM) WAS DONE BEFORE DISCHARGE AND IT WAS "FINE". THE PATIENT WAS DISCHARGED HOME THAT DAY "FOLLOWING A SHORT RECOVERY PERIOD." ON THE FOLLOWING MONTH, THE PHYSICIAN'S NURSE REPORTED SHE HAD JUST SPOKEN TO THE PATIENT AND SHE IS DOING FINE.

    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 08C15HA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other RADIO FREQUENCY CONTROLLER MODEL 09