BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 1881964 · Received October 12, 2010

    Report

    Report Number
    2024601-2010-00865
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    March 18, 2010
    Report Date
    July 28, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). THE ACCESS PORT CONNECTOR ASSOCIATED WITH THIS REPORT HAS NOT BEEN RETURNED AND IS PRESUMED DISCARDED AFTER SURGERY BY THE RPTR. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE RPTR, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE SURGEON IS PRESUMED TO HAVE DISCARDED THE DEVICE WHEN IT WAS EXPLANTED AND IT IS NO LONGER AVAILABLE FOR RETURN. THEREFORE, ALLERGAN WILL NOT RECEIVE IT AND NO ANALYSIS OR TESTING WILL BE 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

    PT REPORTED A FAULTY DEVICE WHEN THERE WAS NO FLUID DURING AN APPOINTMENT. FOLLOW-UP FINDINGS: SURGEON REPORTED THAT DURING A SURGICAL EXPLORATION, THE PORT TUBING WAS FOUND TO BE "PERISHED" AND TWO WEEKS LATER REMOVED AND REPLACED THE 10.0CM LAP-BAND SYSTEM WITH AN APS LAP-BAND SYSTEM. THE EXPLANTED DEVICE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM LTI ALLERGAN NA 1171368

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR