BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 2844296 · Received November 8, 2012

    Report

    Report Number
    2024601-2012-01158
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    August 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT BEEN RETURNED AS THE DEVICE WAS NOT EXPLANTED. BASED UPON THE PARTIAL IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. FURTHER INFO FROM THE REPORTER REGARDING THE SERIAL NUMBER AND THE ACTUAL IMPLANT DATE HAS BEEN REQUESTED. 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

    HEALTH PROFESSIONAL REPORTED AN ALLEGED PORT "LEAK." THE DEVICE WAS FOUND TO HAVE A "LEAK" AFTER THE DOCTOR PERFORMED SEVERAL FILL ADJUSTMENTS AND COULD NOT ASPIRATE ANY FLUID AFTERWARDS. DEVICE REMAINS IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR