BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0 CM

    MDR report key: 1810539 · Received June 18, 2010

    Report

    Report Number
    2024601-2010-00451
    Event Type
    Malfunction
    Date Received
    June 18, 2010
    Date of Event
    April 27, 2010
    Report Date
    May 20, 2010
    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

    TAPER II. (B)(4). HEALTH PROFESSIONAL SENT IN A MEDWATCH TO THE FDA UNDER REPORT (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE SERIAL # 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. 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

    HEALTH PROFESSIONAL REPORTED THAT A LAP-BAND PORT WAS EXPLANTED DUE TO THE "PT [NOT BEING ABLE] TO HOLD THE AMOUNT OF FLUID PLACED IN THE BANDAGE AND THOUGHT TO HAVE LEAK OF PORT AND TUBING DESPITE RADIOLOGIC INJECTION OF THE PORT WITH CONTRAST AND THE INABILITY TO DEMONSTRATE LEAKAGE. THE PT WAS TAKEN TO THE OPERATING ROOM FOR PORT REVISION OF THE LAPAROSCOPIC ADJUSTABLE GASTRIC BAND; PORT WAS INJECTED WITH METHYLENE BLUE USING A HUBER NEEDLE; SMALL PIN HOLE SIZED AREA WITH METHYLENE BLUE LEAKING OUT OF THE SILICONE INJECTION PORT WAS OBSERVED; LOW PROFILE PORT WAS PLACED." THE EXPLANTED PORT WAS REPORTEDLY RETURNED TO ALLERGAN FOR LAB ANALYSIS. FURTHER FOLLOW-UP WILL BE CONDUCTED TO GATHER ADDITIONAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0 CM LTI ALLERGAN NA 1299297

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR