BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL 1100 1.0 CM

    MDR report key: 341912 · Received July 11, 2001

    Report

    Report Number
    2953140-2001-00015
    Event Type
    Injury
    Date Received
    July 11, 2001
    Date of Event
    February 1, 2001
    Report Date
    June 13, 2001
    Manufacturer
    SOMNUS MEDICAL TECHNOLOGIES, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER SERVICE MANAGER ASKED CLINICAL SCIENTIST TO CALL DOCTOR, WHO HAD SOME CLINICAL QUESTIONS ABOUT RF AND FIBRILLATION. SHE CALLED THE DOCTOR AT 2:45 PM IN 06/2001. A PATIENT IN 2001 WAS TREATED WITH THE S2 & M1100 FOR A TURBINATE PROCEDURE. THE PATIENT HAD A HISTORY OF ATRIAL FIBRILLATION 11 YEARS PRIOR, THAT HAD BEEN TREATED AND HAD BEEN STABLE FOR THE PAST 11 YEARS. THE PATIENT DOES NOT HAVE A PACEMAKER OR INTERNAL CARDIAC DEFIBRILLATOR. THE DAY AFTER THE PROCEDURE, THE PATIENT WENT IN TO ATRIAL FIBRILLATION. THE DOCTOR WANTED TO KNOW IF THERE HAD BEEN ANY PRIOR REPORTS. THE PATIENT IS FINE BUT THE DOCTOR WAS CONCERNED, SINCE THE PATIENT MAY NEED A SECOND TREATMENT. THE DOCTOR WAS INFORMED THAT THERE ARE NO KNOWN ATRIAL DEFIBRILLATION OCCURRENCES WITH THE SOMNUS SYSTEM. A LITERATURE REVIEW SHOWED THAT VENTRICULAR FIBRILLATION IS A RARE COMPLICATION OF ELECTROSURGERY, BUT WERE NO REPORTS OF ATRIAL FIBRILLATION. THE DOCTOR WAS ASKED TO FILL OUT THE DATA COLLECTION FORMS FOR THIS PATIENT. THESE WERE FAXED IN 06/2001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31431 MODEL 1100 1.0 CM TISSUE COAGULATING ELECTRODES GEI SOMNUS MEDICAL TECHNOLOGIES, INC. 1100 1.0 CM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening