BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 2191928 · Received July 22, 2011

    Report

    Report Number
    2024601-2011-00601
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    January 1, 2009
    Report Date
    June 27, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE SERIAL 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. INFECTION IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF AN INFECTION AS FOLLOWS: "INFECTION CAN OCCUR IN THE IMMEDIATE POST-OPERATIVE PERIOD OR YEARS AFTER INSERTION OF THE DEVICE. IN THE PRESENCE OF INFECTION OR CONTAMINATION, REMOVAL OF THE DEVICE IS INDICATED."

    Description of Event or Problem · 1

    PT REPORTED THE LAP-BAND DEVICE ALLEGEDLY "NOT HOLDING FLUID AND INFECTION." THE DEVICE WAS REMOVED WITHOUT REPLACEMENT. THE PROBLEM WAS FIRST NOTICED WHEN THE PT WENT IN FOR AN ADJUSTMENT FILL AND REPORTED FEELING NO RESTRICTION. DURING THIS CONSULTATION, THE EXPLANT SURGEON TRIED TO REMOVE THE EXISTING SALINE FROM THE DEVICE BUT THERE WAS LESS FLUID THAN THE SURGEON'S NOTES INDICATED. LATER, THE PT REPORTED AN INFECTION. THE SURGEON REMOVED THE DEVICE WITHOUT REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM LTI ALLERGAN NA 1101850

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention