BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2013213 · Received March 8, 2011

    Report

    Report Number
    2024601-2011-00192
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    September 15, 2009
    Report Date
    February 8, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNK. (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED FOR ANALYSIS. BASED UPON THE IMPLANT DATE RANGE OF (B)(6) 2000 TO (B)(6) 2008, PROVIDED BY THE RPTR, THE CONNECTOR TYPE IS EITHER A TAPER I OR TAPER II. ABSCESS AND ULCERATION 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 DISPLACEMENT AS FOLLOWS: "CARE MUST BE TAKEN TO PLACE THE ACCESS PORT IN A STABLE POSITION AWAY FROM AREAS THAT MAY BE AFFECTED BY SIGNIFICANT WEIGHT LOSS, PHYSICAL ACTIVITY, OR SUBSEQUENT SURGERY. FAILURE TO DO SO MAY RESULT IN THE INABILITY TO PERFORM PERCUTANEOUS BAND ADJUSTMENTS." "ACCESS PORTS HAVE BEEN REPORTED TO BE "FLIPPED" OR INVERTED BASED ON AN OBLIQUE OR SIDE VIEW OF THE PORT BEING MISINTERPRETED." "THERE WERE ADDITIONAL OCCURRENCES OF THESE EVENTS THAT WERE CONSIDERED TO BE NON-SERIOUS. OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYSTEM THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED: PORT DISPLACEMENT." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF ABSCESS AS FOLLOWS: THERE WERE ADDITIONAL OCCURRENCES OF THESE EVENTS THAT WERE CONSIDERED TO BE NON-SERIOUS. OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYSTEM THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED: INCISIONAL INFECTION, INFECTION, ABNORMAL HEALING AND WOULD INFECTION. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF ULCERATION AS FOLLOWS: ULCERATION, GASTRITIS, GASTROESOPHAGEAL REFLUX, HEARTBURN, GAS BLOAT, DYSPHAGIA, DEHYDRATION, CONSTIPATION, AND WEIGHT REGAIN HAVE BEEN REPORTED AFTER GASTRIC RESTRICTION PROCEDURES.

    Description of Event or Problem · 1

    DOCTOR REPORTED EVENTS OF "PORT PROBLEMS" FROM JOURNAL ARTICLE, "THE EFFECTIVENESS OF ADJUSTABLE GASTRIC BANDING: A RETROSPECTIVE 6-YEAR U.S. FOLLOW-UP STUDY", SURG ENDOSC (2011) 25:397-403. THIS MEDWATCH REPRESENTS THE 99 PTS LISTED IN TABLE 5 OF THE ARTICLE WHO WERE DIAGNOSED WITH PORT PROBLEMS THAT WERE BROKEN OUT AS ABSCESS, ULCERATION AND MIGRATION IN THE TEXT ON PAGE 399 OF THE ARTICLE.

    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