BEUDAMED
    FDA Adverse Event Other Summary report: N

    S2 CONTROL UNIT

    MDR report key: 278297 · Received May 15, 2000

    Report

    Report Number
    2953140-2000-00003
    Event Type
    Other
    Date Received
    May 15, 2000
    Date of Event
    December 2, 1999
    Report Date
    May 15, 2000
    Manufacturer
    SOMNUS MEDICAL TECHNOLOGIES, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WITH PACEMAKER WAS BEING TREATED WITH SOMNOPLASTY PALAT PROCEDURE UNDER GENERAL ANESTHESIA. TREATING PHYSICIAN REPORTED THAT PT WAS PREPPED AND WHEN THE SOMNUS SYSTEM FOOT PEDAL WAS DEPRESSED TO INITIATE ENERGY DELIVERY PHYSICIAN NOTICED INTERFERENCE WITH THE PULSE OXIMETERS AND PT'S HEART STOPPED BEATING, I.E. PACEMAKER DID NOT FUNCTION. THE PROCEDURE WAS STOPPED AND PT'S HEART BEGAN BEATING. WHEN DELIVERY OF "R.F." ENERGY WAS RESUMED, PT'S HEART STOPPED BEATING AGAIN. SOMNOPLASTY TREATMENT WAS STOPPED. "PAALAT" TREATMENT GUIDELINES WERE FOLLOWED. (85 DEGREES CELSIUS, 700 JOULES AT MIDLINE). GROUND PAD WAS MOST LIKELY PLACED ON BACK. A CONFERENCE CALL WITH THE TREATING PHYSICIAN, SOMNUS MEDICAL DIRECTOR AND DIRECTOR OF CLINICAL AFFAIRS ENSUED JUST AFTER PT WAS PLACED IN RECOVERY. TREATING PHYSICIANS WERE AWARE OF PACEMAKER WARNING IN PRODUCT LABELING. SOMNUS MEDICAL DIRECTOR SUGGESTED PT'S CARDIOLOGIST BE CONSULTED TO DETERMINE IF PACEMAKER SHOULD BE RESET. NO EVIDENCE OF EQUIPMENT MALFUNCTION WAS NOTED. INTERFERENCE WITH PACEMAKER IS CLEARLY IDENTIFIED IN S2 USER GUIDE AS POTENTIAL HAZARD. USERS ARE INSTRUCTED TO CONSULT ATTENDING CARDIOLOGIST OR PACEMAKER MFR TO DETERMINE COMPATIBILITY OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S2 CONTROL UNIT R.F. SURGICAL GENERATOR GEI SOMNUS MEDICAL TECHNOLOGIES, INC. S2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other