BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 3831924 · Received March 6, 2014

    Report

    Report Number
    2024601-2014-00107
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    June 18, 2013
    Report Date
    February 10, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE ESTIMATED 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 BUT HAS INSTEAD SENT IT TO THE LOCAL COMPETENT AUTHORITY. VISUAL EXAMINATION WOULD CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT AND THE SIZE OF THE BAND. THE REPORTER SENT THE DEVICE TO THE COMPETENT AUTHORITY AND IT IS NO LONGER AVAILABLE FOR RETURN. THEREFORE ALLERGAN WILL NOT RECEIVE IT AND NO ANALYSIS OR TESTING WILL BE DONE. NO ADDITIONAL INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE MODEL NUMBER; SERIAL NUMBER, THE EXACT IMPLANT DATE, DIAGNOSTIC TESTING, PT WEIGHTS. THE DEVICE WAS IMPLANTED AT ANOTHER FACILITY AND THE IMPLANT SURGEON, DEVICE IDENTITY AND EXACT IMPLANT DATE MAYBE UNK TO THE EXPLANTING FACILITY. 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

    HEALTHCARE PROFESSIONAL REPORTED, THE EXPLANTING SURGEON, REMOVED LAP-BAND ON WITH A FRACTURED TUBING/DECOMPRESSION/LEAK. PT WITH GOOD RESULTS FOR PAST SEVEN YEARS WITH WEIGHT LOSS, UNTIL EIGHT MONTHS AGO. ADDITIONAL INFO WAS RECEIVED THAT INCLUDED IN OPERATING REPORT, PHOTO OF THE WHAT APPEARS TO BE THE BAND (9.75CM TO 11.0CM STYLE). APII STYLE ACCESS PORT, AND TUBING IN A SPECIMEN JAR, AND A QUALITY REPORT. IF THE DEVICE IS RETURNED, THE BAND SIZE MAY BE ABLE TO BE DETERMINED. FOLLOW-UP FINDINGS: THE DEVICE WILL NOT BE RETURNED FOR EVAL BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136235 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR