BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRETTA SYSTEM

    MDR report key: 297404 · Received September 22, 2000

    Report

    Report Number
    2954281-2000-00001
    Event Type
    Other
    Date Received
    September 22, 2000
    Date of Event
    August 4, 2000
    Report Date
    September 19, 2000
    Manufacturer
    CURON MEDICAL, INC.
    Product Code
    JOS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A FOLLOW-UP BY THE PHYSICIAN, THE MFR WAS INFORMED THAT THE PT IS IN COMPLETE REMISSION OF GASTROESOPHAGEAL REFLUX DISEASE (FULLY TREATED) AND WITH NO SEQUELAE ASSOCIATED TO THE ADVERSE EVENT.

    Description of Event or Problem · 1

    CURON MEDICAL, INC. WAS NOTIFIED ON 8/25/00, THAT 48 HOURS AFTER A STRETTA PROCEDURE. THE PT DEVELOPED SOME UPPER ABDOMINAL PAIN AND VOMITED FORCEFULLY ON TWO OCCASIONS. ON THE SECOND OCCASION OF VOMITING THEY BROUGHT UP SOME BLOOD. THE PT WAS SEEN AT A LOCAL HOSPITAL'S EMERGENCY ROOM, AND HOSPITALIZED. THE FOLLOWING DAY THEY WERE TRANSFERRED TO ANOTHER HOSPITAL, WHERE THEY REMAINED UNTIL DISCHARGED. THE PT EXPERIENCED NO FURTHER DOCUMENTED BLEEDING. A REVIEW OF X-RAYS FILMS PROVIDED BY THE LOCAL HOSPITAL, PERFORMED BY THE REPORTING PHYSICIAN AND A STAFF RADIOLOGIST REVEALED THAT THERE WAS AN INTRAMURAL SINUS TRACT WITH NO EVIDENCE OF EXTRAVASATION. A SUBSEQUENT BARIUM ESOPHAGRAM PERFORMED SHOWED NO EVIDENCE OF ANY SINUS TRACT, INDICATING FULL CLOSURE. THE PT WAS DISCHARGED FROM THE HOSPITAL UNEVENTFULLY. THE REPORTING PHYSICIAN SAW THE PT AS A F/U ON 8/28/00. PT WAS DOING EXTREMELY WELL, PT HAD NO PAIN AND HAS HAD NO FURTHER BLEEDING. THEY HAVE RECOVERED FROM THIS SAE WITH NO ILL EFFECT. AT NO TIME DID THEY REQUIRE TRANSFUSION, SURGERY OR OTHER INTERVENTION. THE BLEEDING WAS RESOLVED WITH MEDICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRETTA SYSTEM ELECTRO SURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES JOS CURON MEDICAL, INC. 4301K FD-1059

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization