BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG

    MDR report key: 3242892 · Received July 19, 2013

    Report

    Report Number
    2024601-2013-00601
    Event Type
    Injury
    Date Received
    July 19, 2013
    Date of Event
    December 15, 2012
    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. THE DEVICE HAS 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. EROSION, PAIN 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 EROSION, PAIN AND VOMIT AS FOLLOWS: "WARNINGS: PATIENTS 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." "SLIPPAGE AND/OR POUCH DILATATION CAN OCCUR. GASTROESOPHAGEAL REFLUX, NAUSEA AND/ OR VOMITING WITH EARLY OR MINOR SLIPPAGE MAY BE IN SOME CASES SUCCESSFULLY RESOLVED BY BAND DEFLATION. MORE SERIOUS SLIPPAGE 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." "THERE IS A RISK OF BAND EROSION INTO STOMACH ISSUE. EROSION OF THE BAND INTO STOMACH TISSUE HAS BEEN ASSOCIATED WITH REVISION SURGERY, AFTER THE USE OF GASTRIC-IRRITATING MEDICATIONS, AFTER STOMACH DAMAGE AND AFTER EXTENSIVE DISSECTION OR USE OF ELECTROCAUTERY, AND DURING EARLY EXPERIENCE. SYMPTOMS OF BAND EROSION MAY INCLUDE REDUCED WEIGHT LOSS, WEIGHT GAIN, ACCESS POINT INFECTION, OR ABDOMINAL PAIN. RE-OPERATION TO REMOVE THE DEVICE IS REQUIRED." "CAUTION: INSUFFICIENT WEIGHT LOSS MAY BE CAUSED BY POUCH ENLARGEMENT OR MORE INFREQUENTLY OR MORE INFREQUENTLY BAND EROSION, IN WHICH CASE FURTHER INFLATION OF THE BAND WOULD NOT BE APPROPRIATE." "RE-OPERATION FOR BAND EROSION MAY RESULT IN A GASTRECTOMY OF THE AFFECTED AREA. ERODED BANDS HAVE BEEN REMOVED GASTROSCOPICALLY IN A VERY FEW CASES, DEPENDING ON THE DEGREE OF EROSION. CONSULTATION WITH OTHER EXPERIENCED LAP-BAND SYSTEM SURGEON IS STRONGLY ADVISED IN THESE CASES." 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 PATIENT 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." "PATIENTS MUST BE CAUTIONED TO CHEW THEIR FOOD THOROUGHLY. PATIENTS 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."

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED AS "SPOKE WITH PATIENT, WHO WAS HAVING PAIN AND VOMITING SINCE [PAST SIX MONTHS]. FOLLOW UP WITH "FAMILY DOCTOR". UGI DONE SEEN BY SURGEON AT AND LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (VG) REMOVED DUE TO EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338252 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG LTI ALLERGAN NA 1292497

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention NONE PER FACILITY