BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    MDR report key: 3231405 · Received July 15, 2013

    Report

    Report Number
    2024601-2013-00597
    Event Type
    Injury
    Date Received
    July 15, 2013
    Date of Event
    March 2, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS IF IT IS EXPLANTED IN THE FUTURE. THE DEVICE WAS REPOSITIONED AND REMAINS IMPLANTED. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS, IF IT IS EXPLANTED IN THE FUTURE. IT WAS REPOSITIONED DURING THE PROCEDURE AND ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. POUCH DILATION, REFLUX AND HEARTBURN ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF POUCH DILATATION AND REFLUX AS FOLLOWS: "BAND SLIPPAGE AND/OR POUCH DILATATION CAN OCCUR. GASTROESOPHAGEAL REFLUX, NAUSEA AND/OR VOMITING WITH EARLY OR MINOR SLIPPAGE MAY BE SUCCESSFULLY RESOLVED BY BAND DEFLATION IN SOME CASES. MORE SERIOUS SLIPPAGES MAY REQUIRE BAND REPOSITIONING AND/OR REMOVAL. IMMEDIATE RE-OPERATION TO REMOVE THE BAND IS INDICATED IF THERE IS TOTAL STOMA-OUTLET OBSTRUCTION THAT DOES NOT RESPOND TO BAND DEFLATION OR IF THERE IS ABDOMINAL PAIN." "BAND DEFLATION MAY NOT RESOLVE THE DILATATION IF THE STOMA OBSTRUCTION IS DUE TO A SIGNIFICANT GASTRIC SLIPPAGE OR IF THE BAND IS INCORRECTLY PLACED AROUND THE ESOPHAGUS. BAND REPOSITIONING OR REMOVAL MAY BE NECESSARY IF BAND DEFLATION DOES NOT RESOLVE THE DILATATION." "CAUTION: INSUFFICIENT WEIGHT LOSS MAY BE A SYMPTOM OF INADEQUATE RESTRICTION (BAND TOO LOOSE). OR, IT MAY BE A SYMPTOM OF 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." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF REFLUX AND HEARTBURN AS FOLLOWS: "ULCERATION, GASTRITIS, GASTROESOPHAGEAL REFLUX, HEARTBURN, GAS BLOAT, DYSPHAGIA, DEHYDRATION, CONSTIPATION AND WEIGHT REGAIN HAVE BEEN REPORTED AFTER GASTRIC RESTRICTION PROCEDURES." "FLUID SHOULD BE REMOVED FROM THE SYSTEM IF THERE WERE SYMPTOMS OF EXCESSIVE RESTRICTION OR OBSTRUCTION, INCLUDING EXCESSIVE SENSE OF FULLNESS, HEARTBURN, REGURGITATION AND VOMITING. IF SYMPTOMS ARE NOT RELIEVED BY REMOVAL OF THE FLUID, A BARIUM MEAL SHOULD BE USED TO EVALUATE THE ANATOMY."

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED, "PATIENT HAD HEARTBURN AND REFLUX FOR A FEW WEEKS AND A BARIUM SWALLOW CONFIRMED BAND TOO TIGHT AND DILATED POUCH." THE BAND WAS REPOSITIONED AN REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327793 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) LTI ALLERGAN NA 1764093

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention NONE PER FACILITY.