BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 2852691 · Received November 14, 2012

    Report

    Report Number
    2024601-2012-01169
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT BEEN RETURNED AS THE DEVICE WAS NOT EXPLANTED. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER I. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS, IF IT IS EXPLANTED IN THE FUTURE. THE SURGERY HAS NOT OCCURRED, SO ALLERGAN HAS NOT RECEIVED THE DEVICE NOR PERFORMED ANALYSIS AT THIS TIME. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE PT DATE. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FORM THE BAND, THE PORT OR THE CONNECTOR TUBING."

    Description of Event or Problem · 1

    EXPLANT SURGEON REPORTED, [THE BAND] HAS NEVER WORKED OR KEPT FLUID. [THE SURGEON] INTERROGATED THE BAND WITH FLOUR AND THERE IS A CLEAR LEAK IN THE TUBING. [THE SURGEON] THINKS IT IS DISCONNECTED. [THE SURGEON] IS GOING OT BOOK THE PT TO INVESTIGATE AND POSSIBLY REPLACE THE PORT OR THE BAND OF NECESSARY. FOLLOW-UP FINDINGS: AT THIS TIME THE SURGERY HAS NOT BEEN SCHEDULED. NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM LTI ALLERGAN NA S02LB181

    Patients

    Seq Age Sex Outcome Treatment
    1 NI