BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 2122059 · Received May 24, 2011

    Report

    Report Number
    2024601-2011-00377
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    November 29, 2010
    Report Date
    April 26, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: (B)(4) 2011. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS BEEN RETURNED, HOWEVER, HAS NOT BEEN ANALYZED AT THIS TIME. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS RECEIVED THE PRODUCT, HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. VOMITING IS A SURGICAL AND PHYSIOLOGICAL COMPLICATION, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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 REPORTED EVENT OF VOMITING AS FOLLOWS: "NAUSEA AND VOMITING MAY OCCUR, PARTICULARLY IN THE FIRST FEW DAYS AFTER SURGERY AND WHEN THE PT EATS MORE THAN RECOMMENDED."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED AN ALLEGED LEAK ON THE POSTERIOR ASPECT OF THE PORT TUBING. ADDITIONALLY, THE PT PREVIOUSLY EXPERIENCED VOMITING CAUSE BY TOO MUCH RESTRICTION. WHEN THE BAND WAS ASPIRATED AND LOOSENED, THE EVENT WAS RESOLVED. BAND ASPIRATION WAS ALSO USED TO DIAGNOSE THE LEAK. THE PORT WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM LTI ALLERGAN NA 1228422

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention