BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    MDR report key: 2220299 · Received August 16, 2011

    Report

    Report Number
    2024601-2011-00637
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    June 15, 2010
    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). ALLERGAN HAS RECEIVED THE PRODUCT, HOWEVER, NO ANALYSIS OR TESTING HAS BEEN DONE 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. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. BAND SLIPPAGE, POUCH DILATION AND VOMIT 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 BAND SLIPPAGE, POUCH DILATATION AND VOMITING 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 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 BAND DEFLATION DOES NOT RESOLVE THE DILATATION." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF VOMIT AS FOLLOWS: "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."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED: "...[THE PT] NOT TOLERATING SOLIDS OR LIQUIDS, BAND WAS ALREADY DEFILED TO 0CC - HAD DILATED POUCH LAST YEAR AND WAS DEFILED THEN - REFILLED SINCE THAT TIME. SYMPTOMS RETURNED - [BAND SLIPPAGE]..." THE LAP-BAND WAS REMOVED AND WILL BE REPLACED AT A LATER DATE. THE DEVICE WILL BE RETURNED. FOLLOW-UP FINDINGS: EVENT CLARIFIED THAT WHEN THE PT WAS NOT TOLERATING SOLIDS OR LIQUIDS, THE PT WAS VOMITING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) LTI ALLERGAN NA 1600780

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention COZARR 100MG OD| METFORMIN 500 QOD.