BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 1950035 · Received December 7, 2010

    Report

    Report Number
    2024601-2010-00991
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    October 8, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: (B)(4) 2010. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ALLERGAN HAS RECEIVED 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." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF ESOPHAGEAL DILATATION AS FOLLOWS: "ESOPHAGEAL DISTENSION OR DILATATION HAS BEEN REPORTED INFREQUENTLY. THIS IS MOST LIKELY A CONSEQUENCE OF INCORRECT BAND PLACEMENT, OVER-RESTRICTION, STOMA OBSTRUCTION, AND CAN ALSO BE DUE TO EXCESSIVE VOMITING, OR PT NON-COMPLIANCE, AND MAY BE MORE LIKELY IN CASES OF PRE-EXISTING ESOPHAGEAL DYSMOTILITY. DEFLATION OF THE BAND IS RECOMMENDED IF ESOPHAGEAL DILATATION DEVELOPS. A REVISION PROCEDURE MAY BE NECESSARY TO RE-POSITION OR REMOVE THE BAND IF DEFLATION DOES NOT RESOLVE THE DILATION.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED A "PORT REMOVAL DUE TO LEAK AND ESOPHAGEAL DILATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1623323

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention