BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    MDR report key: 1852415 · Received September 29, 2010

    Report

    Report Number
    2024601-2010-00815
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    July 7, 2009
    Report Date
    September 3, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED, THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ALLERGAN HAS RECEIVED THE PRODUCT HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF DYSPHAGIA AS FOLLOWS: "ULCERATION, GASTRITIS, GASTROESOPHAGEAL REFLUX, HEARTBURN, GAS BLOAT, DYSPHAGIA, DEHYDRATION, CONSTIPATION AND WEIGHT REGAIN HAVE BEEN REPORTED AFTER GASTRIC RESTRICTION PROCEDURES." 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 PATIENTS TOTAL)."

    Description of Event or Problem · 1

    MEDICAL STAFF REPORTED, A LAP-BAND DEVICE WAS REMOVED AT THE PATIENT'S REQUEST BECAUSE OF DYSPHAGIA AND MARGINAL WEIGHT LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE) LTI ALLERGAN NA 1385709

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention