BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 1990723 · Received February 8, 2011

    Report

    Report Number
    2024601-2011-00053
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 1, 2010
    Report Date
    January 17, 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

    MEDWATCH SENT TO FDA ON: 02/08/2011. 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 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. BAND SLIPPAGE, DYSPHAGIA, REFLUX AND HEART BURN 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 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 BY 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." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF DYSPHAGIA, REFLUX AND HEARTBURN AS FOLLOWS: "ULCERATION, GASTRITIS, GASTROESOPHAGEAL REFLUX, HEARTBURN, GAS BLOAT, DYSPHAGIA, DEHYDRATION, CONSTIPATION AND WEIGHT REGAIN HAVE BEEN REPORTED AFTER GASTRIC RESTRICTION PROCEDURES." "FLUID SHOULD BE REMOVED FROM THE SYSTEM IF THERE WERE SYMPTOMS OF EXCESSIVE RESTRICTION OR OBSTRUCTION, INCLUDING EXCESSIVE SENSE OF FULLNESS, HEARTBURN, REGURGITATION AND VOMITING. IF SYMPTOMS ARE NOT RELIEVED BY REMOVAL OF THE FLUID, A BARIUM MEAL SHOULD BE USED TO EVALUATE THE ANATOMY."

    Description of Event or Problem · 1

    EVENT REPORTED AS A SLIP. THE 10.0 CM LAP-BAND SYSTEM WAS REMOVED AND REPLACED WITH AN APL LAP-BAND SYSTEM. THE EXPLANTED DEVICE WILL BE RETURNED. F/U FINDINGS: THE PT HAD BEEN NOT TOLERATING SOLIDS, HAD HEARTBURN AND REFLUX FOR A YEAR WHILE LIVING OUT OF COUNTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM LTI ALLERGAN NA 1211044

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE PER PHYSICIAN