BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 2153478 · Received June 21, 2011

    Report

    Report Number
    2024601-2011-00525
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 22, 2011
    Report Date
    June 2, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: (B)(4) 2011. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE CATALOG NUMBER AND 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. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. 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

    HEALTH PROFESSIONAL REPORTED AN ALLEGED LEAK WITH A LAP-BAND DEVICE. THE DOCTOR REPORTED THAT WITHIN THE LAST SIX MONTHS, THE PATIENT HAS NOTICED A LACK OF RESTRICTION. DURING A FILL APPOINTMENT THE SURGEON "PUT IN 8CC'S AND WHEN THE PATIENT CAME BACK, THERE WAS ONLY 6CC'S IN THE BAND". A FLUOROSCOPY WAS PERFORMED, WHICH DID NOT SHOW A LEAK. THE SURGEON "SUSPECTS A SLOW LEAK, WITH AN UNKNOWN LOCATION". EXPLANT SURGERY HAS NOT BEEN SCHEDULED AT THIS TIME. THE DOCTOR WILL NOTIFY ALLERGAN IF ANY TREATMENT OR EXPLANTATION OCCURS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR NONE REPORTED