BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 2894215 · Received December 27, 2012

    Report

    Report Number
    2024601-2012-01337
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    February 7, 2011
    Report Date
    December 5, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. BAND SLIPPAGE, INTOLERANCE, DYSPHAGIA, VOMIT, AND NAUSEA 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 BAND SLIPPAGE, NAUSEA AND VOMIT AS FOLLOW: "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." DEVICE LABELING ADDRESSES THE CONTRAINDICATION FOR PATIENTS REGARDING INTOLERANCE AS FOLLOWS: "PATIENTS 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." "IT IS IMPORTANT TO DISCUSS ALL POSSIBLE COMPLICATIONS AND ADVERSE EVENTS WITH YOUR PATIENT. COMPLICATIONS WHICH MAY RESULT FROM THE USE OF THIS PRODUCT INCLUDE THE RISKS ASSOCIATED WITH THE MEDICATIONS AND METHODS UTILIZED IN THE SURGICAL PROCEDURE, THE RISKS ASSOCIATED WITH ANY SURGICAL PROCEDURE AND THE PATIENT'S DEGREE OF INTOLERANCE TO ANY FOREIGN OBJECT IMPLANTED IN THE BODY." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF DYSPHAGIA 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 REPORTED EVENT OF VOMIT AND NAUSEA 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."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED A LAP-BAND SYSTEM EXPLANT DUE TO INTOLERANCE. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT EXPERIENCED "DYSPHAGIA, N/V [NAUSEA/VOMITING]" AND THAT THERE WAS A "SLIPPED BAND."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1643084

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention