BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2202543 · Received August 5, 2011

    Report

    Report Number
    2024601-2011-00615
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    June 17, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ACCORDING TO THE REPORTER, THE DEVICE WILL NOT BE RETURNED TO ALLERGAN. 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 NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. FURTHER INFORMATION FROM THE REPORTER REGARDING THE SERIAL NUMBER OF THE DEVICE HAS BEEN REQUESTED. 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 INADEQUATE WEIGHT LOSS AS FOLLOWS: "SEVENTY-FIVE SUBJECTS HAD THEIR ENTIRE LAP-BAND SYSTEM EXPLANTED. INSUFFICIENT WEIGHT LOSS WAS ALSO REPORTED AS A CONTRIBUTOR TO THE DECISION TO EXPLANT IN 24 OF THE 75 EXPLANTS (32 PERCENT). (RECORDED AS OF DECEMBER 2000, CLINICAL STUDY, 299 PATIENTS TOTAL)."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED THE REMOVAL OF A LAP-BAND SYSTEM DUE TO AN ALLEGED "LEAK AT THE PORT" AND BECAUSE THE PATIENT "FAILED TO LOSE WEIGHT." THE GASTRIC BAND WAS REMOVED AND FOUND TO HAVE A LEAK IN THE PORT." THE PERSONNEL AT THE MEDICAL FACILITY STATED THAT "WHILE THE DEVICE MAY BE AVAILABLE FOR EVALUATION, IT IS OUR POLICY THAT WE DO NOT RETURN THE DEVICE TO THE MANUFACTURER." THE IMPLANTING AND EXPLANTING PHYSICIANS ARE UNKNOWN. THE IMPLANT DATE AND SERIAL NUMBER ARE UNKNOWN. THE PATIENT'S MEDICAL HISTORY IS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR