BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0 CM

    MDR report key: 2850301 · Received September 21, 2012

    Report

    Report Number
    2024601-2012-00840
    Event Type
    Malfunction
    Date Received
    September 21, 2012
    Date of Event
    July 30, 2012
    Report Date
    August 27, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE USER FACILITY SENT VOLUNTARY MEDWATCH (B)(4). THE REPORTER 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. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. 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: "CAUTION: INSUFFICIENT WEIGHT LOSS MAY BE A SYMPTOM OF INADEQUATE RESTRICTION (BAND TOO LOOSE). OR, IT MAY BE A SYMPTOM OF POUCH OR ESOPHAGEAL ENLARGEMENT, AND MAY BE ACCOMPANIED BY OTHER SYMPTOMS, SUCH AS HEARTBURN, REGURGITATION OR VOMITING. IF THIS IS THE CASE, INFLATION OF THE BAND WOULD NOT BE APPROPRIATE."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED THE EXPLANT AND REPLACEMENT OF A LAP-BAND PORT DUE TO ALLEGED "PROBLEMS WITH WEIGHT LOSS AND MAINTAINING BAND VOLUME [AND] RESTRICTION WITH EVIDENCE OF A LEAK IN THE SYSTEM." THE PHYSICIAN WAS UNABLE TO ASPIRATE "ANY FLUID FROM THE BAND." AFTER EXPLANT SURGERY, THE PHYSICIAN NOTED "EVIDENCE OF EROSION OF THE TUBING AND A LEAK. THERE WAS HOWEVER NO DISTINCT FRACTURE OF THE TUBING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0 CM LTI ALLERGAN NA 1131340

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR WELLBUTRIN