BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    MDR report key: 1171147 · Received September 18, 2008

    Report

    Report Number
    2024601-2008-00686
    Event Type
    Injury
    Date Received
    September 18, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 19, 2008
    Manufacturer
    BIOENTERICS CORP.
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNK. THE RPTR OF THE COMPLAINT WAS ASKED TO RETURN THE PROD FOR ANALYSIS AS WELL AS INDICATE THE PROD SERIAL NUMBER, DATE OF EVENT, IMPLANT DATE AND EXPLANT DATE. THE INFO HAS NOT YET BEEN REC'D BY ALLERGAN. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT REC'D THE PROD AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. FURTHER INFO FROM THE RPTR REGARDING SERIAL NUMBER AND IMPLANT DATE HAS BEEN REQUESTED. DEVICE LABELING ADDRESSES THE REPORTED EVENTS UNDER "ADVERSE EVENTS" AS FOLLOWS: "IT IS IMPORTANT TO DISCUSS ALL POSSIBLE COMPLICATIONS AND ADVERSE EVENTS WITH YOUR PT. COMPLICATIONS WHICH MAY RESULT FROM THE USE OF THIS PROD INCLUDE THE RISKS ASSOCIATED WITH THE MEDICATIONS AND METHODS UTILIZED IN THE SURGICAL PROCEDURE, THE RISKS ASSOCIATED WITH ANY SURGICAL PROCEDURE AND THE PT'S DEGREE OF INTOLERANCE TO ANY FOREIGN OBJECT IMPLANTED IN THE BODY."

    Description of Event or Problem · 1

    REPORTED AS: "BETWEEN EARLY 1999 AND 2007, LAGB'S HAVE BEEN PERFORMED IN A TOTAL PTS. MEAN HOSP STAY HAS BEEN 2.5 DAYS. MORTALITY HAS BEEN ZERO. MAJOR COMPLICATIONS INCLUDED 19 SLIPPAGES, 7 OUTLET OBSTRUCTIONS, 1 INTRAGASTRIC MIGRATION, 2 ESOPHAGEAL DILATATIONS, 7 BAND INTOLERANCES. SLIPPAGE REQUIRED REMOVAL IN 12 CASES; IN SOME PTS, A NEW BAND REPOSITIONED; IN ONE PT, A GASTRIC REDUCTION WAS PERFORMED; AND IN ONE, A SLEEVE GASTRECTOMY. WE ROUTINELY USED THE 9.75 CM LAPBAND IN THE FIRST PHASE, AND LATELY (SINCE 2005) THE 11 CM BAND." FROM LITERATURE REVIEW: JOURNAL ABSTRACT: "LAPAROSCOPIC ESOPHAGO-GASTRIC BANDING: HOW TO PREVENT AND DEAL WITH COMPLICATIONS" S BOSCHI, ET AL, BOLOGNA, ITALY, PUBLISHED IN "OBES SURG 2008" SPRINGER SCIENCE.

    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 BIOENTERICS CORP. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention