BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK ISZE)

    MDR report key: 1488741 · Received September 30, 2009

    Report

    Report Number
    2024601-2009-00774
    Event Type
    Injury
    Date Received
    September 30, 2009
    Date of Event
    February 1, 2001
    Report Date
    August 31, 2009
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON: 09/30/2009. THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED, AS IT IS NO LONGER AVAILABLE. 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. BAND SLIPPAGE, INADEQUATE WEIGHT LOSS, AND INFECTION ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING: "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." "CAUTION: INSUFFICIENT WEIGHT LOSS MAY BE A SYMPTOM OF INADEQUATE RESTRICTION (BAND TOO LOOSE), POUCH OR ESOPHAGEAL ENLARGEMENT, AND MAY BE ACCOMPANIED BY OTHER SYMPTOMS, SUCH AS HEARTBURN, REGURGITATION OR VOMITING. IF THIS IS THE CASE, INFLATION OF THE BAND WOULD NOT BE APPROPRIATE." "INFECTION CAN OCCUR IN THE IMMEDIATE POST-OPERATIVE PERIOD, OR YEARS AFTER INSERTION OF THE DEVICE. IN THE PRESENCE OF INFECTION OR CONTAMINATION, REMOVAL OF THE DEVICE IS INDICATED."

    Description of Event or Problem · 1

    REPORTED EVENTS OF "BAND MIGRATION", "WEIGHT REGAIN", AND "PORT INFECTION", FROM JOURNAL ARTICLE: "EXPERIENCES OF TWO CENTERS OF BARIATRIC SURGERY IN THE TREATMENT OF INTRAGASTRALE BAND MIGRATION AFTER GASTRIC BANDING - THE IMPORTANCE OF THE MULTICENTER OBSERVATION STUDY FOR QUALITY ASSURANCE IN OBESITY SURGERY 2005 AND 2006", INT J COLORECTAL DIS (2008) 23:901-908 SPRINGER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention