BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    MDR report key: 2220296 · Received August 16, 2011

    Report

    Report Number
    2024601-2011-00709
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    May 10, 2011
    Report Date
    July 22, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE WAS NOT YET BEEN RECEIVED BY ALLERGAN. 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. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. HIATUS HERNIA, VOMITING AND INTOLERANCE 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 EVENT OF VOMIT AS FOLLOWS: "NAUSEA AND VOMITING MAY OCCUR, PARTICULARLY IN THE FIRST FEW DAYS AFTER SURGERY AND WHEN THE PT EATS MORE THAN RECOMMENDED." "NAUSEA AND VOMITING MAY ALSO BE SYMPTOMS OF STOMA OBSTRUCTION OR A BAND/STOMACH SLIPPAGE. FREQUENT, SEVERE VOMITING CAN RESULT IN POUCH DILATATION, STOMACH SLIPPAGE OR ESOPHAGEAL DILATATION. DEFLATION OF THE BAND IS IMMEDIATELY INDICATED IN ALL OF THESE SITUATIONS. DEFLATION OF THE BAND MAY ALLEVIATE EXCESSIVELY RAPID WEIGHT LOSS AND NAUSEA AND VOMITING, OR RE-OPERATION TO REPOSITION OR REMOVE THE DEVICE MAY BE REQUIRED." "PTS MUST BE CAUTIONED TO CHEW THEIR FOOD THOROUGHLY. PTS WITH DENTURES MUST BE CAUTIONED TO BE PARTICULARLY CAREFUL TO CUT THEIR FOOD INTO SMALL PIECES. FAILURE TO FOLLOW THESE PRECAUTIONS MAY RESULT IN VOMITING, STOMAL IRRITATION AND EDEMA, POSSIBLY EVEN OBSTRUCTION." "'PTS MUST BE CAREFULLY COUNSELED ON THE NEED TO REPORT ALL VOMITING, ABDOMINAL PAIN OR OTHER GASTROINTESTINAL OR NUTRITIONAL ISSUES AS THESE SYMPTOMS MAY INDICATE A CONDITION NOT RELATED TO THE LAP-BAND SYSTEM." DEVICE LABELING ADDRESSES THE CONTRAINDICATION FOR PTS REGARDING INTOLERANCE AS FOLLOWS: "PTS WHO ARE KNOWN TO HAVE, OR SUSPECTED TO HAVE, AN ALLERGIC REACTION TO MATERIALS CONTAINED IN THE SYSTEM OR WHO HAVE EXHIBITED PAIN INTOLERANCE TO IMPLANTED DEVICES." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF HERNIA AS FOLLOWS: "A LARGE HIATAL HERNIA MAY PREVENT ACCURATE POSITIONING OF THE DEVICE. PLACEMENT OF THE BAND SHOULD BE CONSIDERED ON A CASE-BY-CASE BASIS DEPENDING ON THE SEVERITY OF THE HERNIA."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED A PT HAVING VOMITING. THE BAND WAS DEFILED AND THE PT WAS STILL UNABLE TO TOLERATE FLUIDS. THERE WAS NO SLIP OR DELATED POUCH SEEN. A GASTROSCOPY WAS PERFORMED AND A MUCOSAL BIOPSY TAKEN WHICH WAS NEGATIVE. THE APS LAP-BAND WAS REPORTED AS BEING TOO SMALL. AN APL LAP-BAND WAS INSERTED AND A HIATUS HERNIA REPAIRED. THE EXPLANTED DEVICE WILL BE RETURNED. PER THE HEALTH PROFESSIONAL THERE IS NO EXPLANATION WHY THE PT STARTED TO EXPERIENCE THE SYMPTOMS AFTER TWO YEARS AND SEVEN MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) LTI ALLERGAN NA 1647878

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention NONE KNOWN PER PHYSICIAN.