BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    MDR report key: 1373528 · Received April 30, 2009

    Report

    Report Number
    2024601-2009-00387
    Event Type
    Injury
    Date Received
    April 30, 2009
    Date of Event
    January 1, 2005
    Report Date
    April 2, 2009
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNK. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS INDICATE THE PRODUCT SERIAL NUMBER, DATE OF EVENT, IMPLANT DATE AND EXPLANT DATE. SINCE ALLERGAN HAS NOT YET RECEIVED THIS INFORMATION THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. ESOPHAGEAL DILATATION IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING: "ESOPHAGEAL DISTENSION OR DILATATION HAS BEEN REPORTED INFREQUENTLY. THIS IS MOST LIKELY A CONSEQUENCE OF INCORRECT BAND PLACEMENT, OVER-RESTRICTION, STOMA OBSTRUCTION, AND CAN ALSO BE DUE TO EXCESSIVE VOMITING, OR PT NON-COMPLIANCE, AND MAY BE MORE LIKELY IN CASES OF PRE-EXISTING ESOPHAGEAL DYSMOTILITY. DEFLATION OF THE BAND IS RECOMMENDED IF ESOPHAGEAL DILATATION DEVELOPS. A REVISION PROCEDURE MAY BE NECESSARY TO RE-POSITION OR REMOVE THE BAND IF DEFLATION DOES NOT RESOLVE THE DILATION."

    Description of Event or Problem · 1

    REPORTED EVENT OF ESOPHAGEAL DILATATION FROM JOURNAL ARTICLE: "LAPAROSCOPIC SLEEVE GASTRECTOMY AFTER GASTRIC BANDING REMOVAL: A FEASIBILITY STUDY". SURGICAL INNOVATION VOL. 16, NO. 1 MARCH 2009 68-72 SAGE PUBLICATIONS 10.1177/1553350608328866.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM DEVICE FOR TREATMENT OF MORBID OBESITY LTI COSTA RICA NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention