BEUDAMED
    FDA Adverse Event Death Summary report: N

    STRETTA SYSTEM

    MDR report key: 308934 · Received December 12, 2000

    Report

    Report Number
    2954281-2000-00008
    Event Type
    Death
    Date Received
    December 12, 2000
    Date of Event
    November 11, 2000
    Report Date
    December 12, 2000
    Manufacturer
    CURON MEDICAL, INC.
    Product Code
    JOS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS PT UNDERWENT AN ENDOSCOPIC PROCEDURE TO TREAT THEIR GASTROESOPHAGEAL REFLUX DISEASE (GERD) ON 11/11/2000. PHYSICIAN REPORTED THAT THE CASE WAS UNEVENTFUL AND THAT THE CATHETER AND GENERATOR PERFORMED PROPERLY. ON 11/13/2000, THE PT DEVELOPED A FEVER AND CHEST DISCOMFORT. A CHEST RADIOGRAPH DEMONSTRATED AN UNILATERAL PNEUMONIA CONSISTENT WITH ASPIRATION OF SECRETIONS EITHER DURING OR AFTER THE PROCEDURE. THE PT CARRIED A DIAGNOSIS OF ALZHEIMER'S DISEASE AND, THEREFORE, MAY HAVE HAD ADD'L ALTERED MENTAL STATUS DURING RECOVERY THAT PRECIPITATED THIS EVENT. THE PT WAS ADMITTED TO THE HOSP AND BEGUN ON INTRAVENOUS ANTIBIOTICS. WHILE ASPIRATION PNEUMONIA IS NOT DIRECTLY RELATED TO THE DELIVERY OF RF ENERGY, THIS COMPLICATION IS PROCEDURALLY RELATED AND THE COMPANY THEREFORE CHOSE TO REPORT THE EVENT. AFTER ADMISSION, THE PHYSICIAN ORDERED A GASTROGRAFFIN CONTRAST SWALLOWING STUDY, THE INDICATION FOR WHICH IS UNKNOWN. AFTER THE STUDY, WHICH WAS NORMAL, THE PT VOMITED AND ASPIRATED GASTRIC CONTENTS AND CONTRAST MATERIAL, PRECIPITATING ADULT RESPIRATORY DISTRESS SYNDROME (ARDS). THE PT WAS CARED FOR IN THE INTENSIVE CARE UNIT. AFTER DISCUSSION WITH THE PHYSICIAN, THE FAMILY ELECTED TO WITHHOLD VENTILATORY SUPPORT DUE TO THE PT'S FAILING MENTAL HEALTH AND PREVIOUS WISHES NOT TO BE MAINTAINED ON INTENSIVE SUPPORT IN SUCH CASES. THE PT EXPIRED ON 11/19/2000. THIS EVENT WAS NOT RELATED TO THE DELIVERY OF RF ENERGY, BUT IS NONETHELESS PROVIDED AS FOLLOW-UP TO THE PT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRETTA SYSTEM ELECTRO SURGICAL CUTTING & COAGULATION DEVICE & ACCESORIES. JOS CURON MEDICAL, INC. 4301 FD1065

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death