BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 1852434 · Received September 29, 2010

    Report

    Report Number
    2024601-2010-00798
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 2, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNK. (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS TO INDICATE THE PRODUCT SERIAL NUMBER AND THE IMPLANT DATE. THE INFO HAS NOT YET BEN RECEIVED BY ALLERGAN. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION BE MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. FURTHER INFORMATION FROM THE REPORTER REGARDING THE SERIAL NUMBER AND THE IMPLANT DATE HAS BEEN REQUESTED. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF INADEQUATE WEIGHT LOSS AS FOLLOWS: "SEVENTY-FIVE SUBJECTS HAD THEIR ENTIRE LAP-BAND SYSTEM EXPLANTED. INSUFFICIENT WEIGHT LOSS WAS ALSO REPORTED AS A CONTRIBUTOR TO THE DECISION TO EXPLANT IN 24 OF THE 75 EXPLANTS (32%). (RECORDED AS OF (B)(6) 2000, CLINICAL STUDY, 299 PTS TOTAL)."

    Description of Event or Problem · 1

    ALLERGAN SALES REPRESENTATIVE REPORTED ON BEHALF OF THE EXPLANTING PHYSICIAN THE EXPLANTATION OF A LAP-BAND SYS 10.0CM, AS THERE WERE "WEIGHT LOSS CONCERNS [AND THE] PT REPORTS INTOLERABILITY." FURTHER FOLLOW UP WILL BE CONDUCTED TO GATHER ADDITIONAL INFO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention