BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    MDR report key: 3130224 · Received May 22, 2013

    Report

    Report Number
    2024601-2013-00409
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    September 17, 2012
    Report Date
    April 26, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT WAS RETURNED; HOWEVER, THE DEVICE ANALYSIS RESULTS ARE PENDING AT THIS TIME. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS RECEIVED THE PRODUCT; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING."

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED A "SUSPECTED PORT LEAK" ON A LAP-BAND SYSTEM WHICH WAS FIRST NOTICED WHEN THE PORT WAS "MISSING 3CC" AND THEN "MISSING ANOTHER 3CC ABOUT SIX MONTHS LATER. THE PORT WAS REMOVED AND REPLACED WITH A NEWER MODEL (RAPID PORT EZ).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227725 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE) LTI ALLERGAN NA 1778431

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR