BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 2220050 · Received August 9, 2011

    Report

    Report Number
    2024601-2011-00624
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    June 17, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ALLERGAN HAS REC'D THE PRODUCT HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. 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

    MEDICAL STAFF REPORTED AN ALLEGED LAP-BAND DEVICE TUBING LEAK. THE DEVICE WAS REMOVED BECAUSE, THE "TUBING DISCONNECTED FROM LAP-BAND SYSTEM WHILE IN PT." MEDICAL STAFF REPORTED AN ALLEGED LAP-BAND DEVICE TUBING LEAK. THE ENTIRE SYSTEM WAS REMOVED BECAUSE, THE "TUBING DISCONNECTED FROM LAP-BAND SYSTEM WHILE IN PT." F/U FINDINGS: AN "UPPER GI" WAS PERFORMED AND THE SURGEON SAW THAT "THE PORT TUBING WAS CRACKED." THE PROBLEM WAS FIRST NOTED WHEN THE PT CAME IN TO THE OFFICE AND SAID, THE PT HAD "GAINED WEIGHT," FELT "NO RESTRICTION," AND WAS EXPERIENCING "HUNGER BETWEEN MEALS." THE SURGEON "COULDN'T WITHDRAW FLUID" FROM THE BAND. THE ENTIRE SYSTEM WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1603514

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR INITIAL WEIGHT: (B)(6) LBS,| CURRENT WEIGHT: (B)(6) LBS.