BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 3101809 · Received May 3, 2013

    Report

    Report Number
    2024601-2013-00314
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    January 9, 2013
    Report Date
    April 8, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALLERGAN HAS RECEIVED THE PRODUCT HOWEVER THE DEVICE HAS NOT BEEN IDENTIFIED NOR HAS THE ANALYSIS BEEN COMPLETED AT THIS TIME. BASED UPON THE MODEL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER. 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

    HEALTHCARE PROFESSIONAL REPORTED A LAP-BAND PORT "LEAK." THE EVENT WAS FIRST NOTED WHEN THE "PATIENT CAME FOR FILL" AND THE PHYSICIAN WAS "UNABLE TO PULL BACK CORRECT AMOUNT OF FLUID SUPPOSED TO BE IN LAP BAND [LAP-BAND]. THE PORT WAS EXPLANTED AND REPLACED. AT THE TIME OF EXPLANT IT WAS NOTED THAT THE "PORT HAS CLEAR BLUE RING AROUND BACK OF PORT DUE TO LEAK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195164 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR