BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2000961 · Received February 18, 2011

    Report

    Report Number
    2024601-2011-00089
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    January 1, 2010
    Report Date
    January 25, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPPER II. (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED ON THE IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. FURTHER INFORMATION FROM THE REPORTER REGARDING THE SERIAL NUMBER HAS BEEN REQUESTED. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF EROSION AS FOLLOWS: "THERE IS A RISK OF BAND EROSION INTO STOMACH TISSUE." "RE-OPERATION TO REMOVE THE DEVICE IS REQUIRED." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF BAND SLIPPAGE AND VOMITING AS FOLLOWS: "SLIPPAGE OF THE BAND CAN OCCUR. GASTROESOPHAGEAL REFLUX, NAUSEA AND/OR VOMITING WITH EARLY OR MINOR SLIPPAGE MAY IN SOME CASES BE RESOLVED BY BAND DEFLATION. MORE SERIOUS SLIPPAGES MAY REQUIRE BAND REPOSITIONING AND/OR REMOVAL." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF DYSPHAGIA AND REFLUX 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

    COMPANY REPRESENTATIVE REPORTED ON BEHALF OF A HEALTH PROFESSIONAL THAT A LAP-BAND REMOVAL AND REPLACEMENT WAS DONE BECAUSE OF PROLAPSE AND EROSION. THE PATIENT ALSO EXPERIENCED SYMPTOMS OF VOMITING, REFLUX, AND DYSPHAGIA THAT RESULTED IN A SERIES OF DRAINING AND REFILLING OF THE BAND.

    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