BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 2771972 · Received October 2, 2012

    Report

    Report Number
    2024601-2012-00896
    Event Type
    Injury
    Date Received
    October 2, 2012
    Date of Event
    June 14, 2012
    Report Date
    September 5, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALLERGAN HAS RECEIVED THE PRODUCT. HOWEVER, THE DEVICE HAS NOT BEEN IDENTIFIED NOR HAS THE ANALYSIS BEEN COMPLETED AT THIS TIME. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. INTOLERANCE AND "REFRACTORY MORBID OBESITY" ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. HEALTH PROFESSIONAL HAS DECLINED TO PROVIDE ADDITIONAL INFORMATION. DEVICE LABELING ADDRESSES THE POTENTIAL OF INTOLERANCE AS FOLLOWS: "IT IS IMPORTANT TO DISCUSS ALL POSSIBLE COMPLICATIONS AND ADVERSE EVENTS WITH YOUR PATIENT. COMPLICATIONS WHICH MAY RESULT FROM THE USE OF THIS PRODUCT INCLUDE THE RISKS ASSOCIATED WITH THE MEDICATIONS AND METHODS UTILIZED IN THE SURGICAL PROCEDURE, THE RISKS ASSOCIATED WITH ANY SURGICAL PROCEDURE AND THE PATIENT'S DEGREE OF INTOLERANCE TO ANY FOREIGN OBJECT IMPLANTED IN THE BODY." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF "REFRACTORY MORBID OBESITY" AS FOLLOWS: "CAUTION: INSUFFICIENT WEIGHT LOSS MAY BE A SYMPTOM OF INADEQUATE RESTRICTION (BAND TO LOOSE), POUCH OR ESOPHAGEAL ENLARGEMENT, AND MAY BE ACCOMPANIED BY OTHER SYMPTOMS, SUCH AS HEARTBURN, REGURGITATION OR VOMITING. IF THIS IS THE CASE, INFLATION OF THE BAND WOULD NOT BE APPROPRIATE.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED, "BAND AND PORT EXPLANTED DUE TO LAP-BAND INTOLERANCE AND REFRACTORY MORBID OBESITY. SWITCHED TO SLEEVE GASTRECTOMY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 2066152

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention