BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTE, (UNK SIZE)

    MDR report key: 3130267 · Received May 22, 2013

    Report

    Report Number
    2024601-2013-00390
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 22, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. 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 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. EROSION IS A SURGICAL AND PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OF THE DEVICE. 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. CAUTION: FAILURE TO CREATE A STABLE, SMOOTH PATH FOR THE ACCESS PORT TUBING, WITHOUT SHARP TURNS OR BENDS, CAN RESULT IN TUBING BREAKS AND LEAKAGE."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED A "PORT LEAK" OF A LAP-BAND SYSTEM. THE REPORTER ALSO NOTED THAT THE "PORT MALFUNCTION WAS SECONDARY TO AN EROSION OF THE CONNECTING TUBE ON [THE ] FASCIA." THE LAP-BAND WAS REMOVED, AND IT IS NOT KNOWN IF IT WAS REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE REPORTER, AT THIS TIME, AND THE PRODUCT RETURN IS CURRENTLY PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227785 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTE, (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR