BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 3133157 · Received May 24, 2013

    Report

    Report Number
    2024601-2013-00407
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    June 17, 2011
    Report Date
    April 29, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT WAS RETURNED HOWEVER THE DEVICE ANALYSIS RESULTS ARE PENDING AT THIS TIME. BASED UPON THE IMPLANT DATE AND PRODUCT TYPE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS RECEIVED THE PRODUCT HOWEVER THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. OBSTRUCTION, DYSPHAGIA, REGURGITATION (REFLUX), AND WEIGHT FLUCTUATIONS (INADEQUATE WEIGHT LOSS) ARE SURGICAL AND PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OF THE DEVICE. DEVICE LABELING ADDRESSES THE REPORTED EVENT AS FOLLOWS: OBSTRUCTION OF STOMAS HAS BEEN REPORTED AS BOTH AN EARLY AND A LATE COMPLICATION OF THIS PROCEDURE. THIS CAN BE CAUSED BY EDEMA, FOOD, IMPROPER INITIAL CALIBRATION, BAND SLIPPAGE, POUCH TORSION, OR PATIENT NONCOMPLIANCE REGARDING CHOICE AND CHEWING OF FOOD. ULCERATION, GASTRITIS, GASTROESOPHAGEAL REFLUX, HEARTBURN, GAS BLOAT, DYSPHAGIA, DEHYDRATION, CONSTIPATION AND WEIGHT REGAIN HAVE BEEN REPORTED AFTER GASTRIC RESTRICTION PROCEDURES." INADEQUATE WEIGHT LOSS AND VOMITING ARE ADDRESSED IN THE LABELING. ALLERGAN DOES NOT GUARANTEE THAT EVERY PATIENT WILL ACHIEVE DESIRED WEIGHT LOSS. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF INADEQUATE WEIGHT LOSS AS FOLLOWS: (B)(4).

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED A LAP-BAND SYSTEM "WASN'T WORKING FOR THE PATIENT" AND THE PATIENT WAS "GAINING WEIGHT." THE PATIENT CAME INTO THE OFFICE FOR A FILL COMPLAINING OF DYSPHAGIA. PATIENT ALSO PREVIOUSLY HAD "PORK CHOPS STUCK IN ESOPHAGUS, WHICH CAUSED REGURGITATION." THE LAP-BAND SYSTEM WAS REMOVED AND NOT REPLACED. THE SERIAL NUMBER OF THE DEVICE WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232093 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention