BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2314791 · Received October 26, 2011

    Report

    Report Number
    2024601-2011-00864
    Event Type
    Injury
    Date Received
    October 26, 2011
    Date of Event
    January 31, 2011
    Report Date
    September 27, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNK. (B)(4). MULTIPLE REQUESTS FOR FURTHER INFO HAVE BEEN MADE. ALLERGAN HAS RECEIVED NO RESPONSE FROM THE REPORTER. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. VISUAL EXAM MAY DETERMINE THE CONNECTOR TYPE WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. ALTHOUGH THE MFR OF THE DEVICE IS UNK, IT IS ALLERGAN'S APPROACH TO COMPLIANCE TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING. EROSION IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF EROSION AS FOLLOWS: "AS WITH OTHER GASTROPLASTY SURGERIES, PARTICULAR CARE MUST BE TAKEN DURING DISSECTION AND DURING IMPLANTATION OF THE DEVICE TO AVOID DAMAGE TO THE GASTROINTESTINAL TRACT. ANY DAMAGE TO THE STOMACH DURING THE PROCEDURE MAY RESULT IN EROSION OF THE DEVICE INTO THE GI TRACT." "OVER-DISSECTION OF THE STOMACH DURING PLACEMENT MAY RESULT IN SLIPPAGE OR EROSION OF THE BAND AND REQUIRE REOPERATION." "THERE IS A RISK OF BAND EROSION INTO STOMACH TISSUE. 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."

    Description of Event or Problem · 1

    REPORTED EVENT OF "BAND EROSION" FROM RESEARCH ARTICLE: "BARIATRIC SURGERY: A REVIEW OF NORMAL POSTOPERATIVE ANATOMY AND COMPLICATIONS", CLINICAL RADIOLOGY 66(2011) 903-914. MFR OF DEVICE IS UNK. IT IS ALLERGAN'S APPROACH TO COMPLIANCE TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING.

    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