BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    MDR report key: 1931197 · Received November 11, 2010

    Report

    Report Number
    2024601-2010-00884
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    July 20, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED AND REMAINS IMPLANTED AT THIS TIME. BASED UPON 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 RETURNED THE PRODUCT FOR ANALYSIS, IF IT MAY BE EXPLANTED. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF A LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING." 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 IMPLANTS (32%). (RECORDED AS OF DECEMBER 2000, CLINICAL STUDY, 299 PTS TOTAL)."

    Description of Event or Problem · 1

    PT REPORTED A LEAKING PORT ON A LAP-BAND DEVICE. THE PT STATED THAT THE "LEAK WAS CONFIRMED BY A BARIUM STUDY CONDUCTED BY THE IMPLANTING PHYSICIAN." THE DEVICE REMAINS IMPLANTED AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR