BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2192427 · Received July 26, 2011

    Report

    Report Number
    2024601-2011-00584
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 27, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS TO INDICATE THE PRODUCT SERIAL NUMBER, DATE OR EVENT AND PT DETAILS. THE INFO HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE 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. VOMIT, OBSTRUCTION AND REFLUX 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 OBSTRUCTION AS FOLLOWS: "SLIPPAGE OF THE BAND CAN OCCUR. GASTRO-ESOPHAGEAL REFLUX, NAUSEA AND/OR VOMITING WITH EARLY OR MINOR SLIPPAGE MAY BE IN SOME CASES SUCCESSFULLY RESOLVED BY BAND DEFLATION. MORE SERIOUS SLIPPAGES MAY REQUIRE BAND REPOSITIONING AND/OR REMOVAL. IF THERE IS TOTAL STOMA OUTLET OBSTRUCTION THAT DOES NOT RESPOND TO BAND DEFLATION, OR IF THERE IS ABDOMINAL PAIN, THEN IMMEDIATE RE-OPERATION TO REMOVE THE BAND IS INDICATED." "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 PT NON-COMPLIANCE REGARDING CHOICE AND CHEWING OF FOOD." "CAUTION: ESOPHAGEAL DISTENSION OR DILATATION HAS BEEN REPORTED TO RESULT FROM STOMA OBSTRUCTION DUE TO OVER-RESTRICTION, DUE TO EXCESSIVE BAND INFLATION. PTS SHOULD NOT EXPECT TO LOSE WEIGHT AS FAST AS GASTRIC BYPASS PTS, AND BAND INFLATION SHOULD PROCEED IN SMALL INCREMENTS. DEFLATION OF THE BAND IS RECOMMENDED IF ESOPHAGEAL DILATATION DEVELOPS." "CAUTION: IT IS THE RESPONSIBILITY OF THE SURGEON TO ADVISE THE PT OF THE DIETARY RESTRICTIONS WHICH FOLLOW THIS PROCEDURE AND TO PROVIDE DIET AND BEHAVIOR MODIFICATION SUPPORT. FAILURE TO ADHERE TO THE DIETARY RESTRICTIONS MAY RESULT IN OBSTRUCTION AND/OR FAILURE TO LOSE WEIGHT." "CAUTION: 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." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF VOMIT AND NAUSEA 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 EXCESSIVE RAPID WEIGHT LOSS AND NAUSEA AND VOMITING, OR RE-OPERATION TO REPOSITION OR REMOVE THE DEVICE MAY BE REQUIRED." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF REFLUX AS FOLLOWS: "ULCERATION, GASTRITIS, GASTROESOPHAGEAL REFLUX, HEARTBURN, GAS BLOAT, DYSPHAGIA, DEHYDRATION, CONSTIPATION AND WEIGHT REGAIN HAVE BEEN REPORTED AFTER GASTRIC RESTRICTION PROCEDURES." DEVICE LABELING ADDRESSES THE POTENTIAL OF ADVERSE EVENTS AS FOLLOWS: "CAUTION: IT IS THE RESPONSIBILITY OF THE SURGEON TO ADVISE THE PT OF THE KNOWN RISKS AND COMPLICATIONS ASSOCIATED WITH THE SURGICAL PROCEDURE AND IMPLANT."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED A PT COMPLAINING OF VOMITING AND REFLUX. THE PHYSICIAN DID AN ENDOSCOPY AND FOUND FLUID IN THE ESOPHAGUS. THE PHYSICIAN PERFORMED AN UPPER GI WHICH FOUND A "GASTRIC OUTLET OBSTRUCTION." THE PHYSICIAN ALSO FOUND A STITCH INSIDE THE STOMACH. THE PHYSICIAN IS UNSURE IF THE STITCH IS RELATED TO OR THE CAUSE OF THE ISSUES. THE DEVICE HAS BEEN REMOVED WITHOUT REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention