BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORBERA INTRAGASTRIC BALLOON SYSTEM

    MDR report key: 19330726 · Received May 16, 2024

    Report

    Report Number
    3005099803-2024-02331
    Event Type
    Injury
    Date Received
    May 16, 2024
    Date of Event
    February 1, 2024
    Report Date
    May 16, 2024
    Manufacturer
    APOLLO ENDOSURGERY, INC
    Product Code
    LTI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EVENT DATE ESTIMATED. ACTUAL DATE UNKNOWN. BLOCK H6: IMDRF CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION OR PROLONGED HOSPITALIZATION. IMDRF CODE F2202 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL ENDOSCOPIC PROCEDURE. IMDRF CODE E0618 CAPTURES THE REPORTABLE EVENT OF EKG. IMDRF CODE E2327 CAPTURES THE REPORTABLE EVENT OF NECROSIS. IMDRF CODE E2330 CAPTURES THE REPORTABLE EVENT OF PAIN. IMDRF CODE E233001 CAPTURES THE REPORTABLE EVENT OF CHEST PAIN. IMDRF CODE E2328 CAPTURES THE REPORTABLE EVENT OF OBSTRUCTION. IMDRF CODE A010402 CAPTURES THE REPORTABLE EVENT OF MIGRATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORBERA BALLOON WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN EVENT DATE. THE DAY FOLLOWING THE PROCEDURE, THE PATIENT PRESENTED TO THE CLINIC WITH CHEST PAIN, AND AN EKG WAS PERFORMED. THE PATIENT WAS SENT TO THE EMERGENCY ROOM. A CT SCAN DISPLAYED AN OBSTRUCTION, AND THE BALLOON WAS REMOVED. THE PHYSICIAN WAS INFORMED THE PATIENT ALSO PRESENTED LATER WITH STOMACH AND ESOPHAGUS NECROSES AND SUFFERS FROM CHRONIC PAIN. PATIENT CURRENT CONDITION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474345 ORBERA INTRAGASTRIC BALLOON SYSTEM IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI APOLLO ENDOSURGERY, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| O| H