BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    -BAND ACCESS PORT KIT (UNK SIZE)

    MDR report key: 3030832 · Received March 28, 2013

    Report

    Report Number
    2024601-2013-00216
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    October 18, 2012
    Report Date
    March 4, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS EITHER A TAPER II OR RAPID PORT EZ STRAIN RELIEF. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OR MODEL 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

    PT REPORTED THEIR LAP-BAND SYSTEM HAS "COME APART WHERE THE BAND CONNECTS TO THE TUBE IN THE STOMACH." THE EVENT WAS NOTED "AFTER SEVERAL TIMES OF TRYING TO DO AN ADJUSTMENT WHICH WAS UNSUCCESSFUL." PHYSICIAN NOTED "INJECTION OF THE PORT WAS PERFORMED WITH STERILE SALINE. HOWEVER, NO RETURN OF INJECTED FLUID WAS IDENTIFIED WITH ASPIRATION. THERE APPEARS TO BE DISCONTINUITY BETWEEN THE GASTRIC BAND AND THE TUBING MATERIAL." THE PHYSICIAN NOTED THE "BAND DETACHED RIGHT BELOW WHERE THE KNOB IS ON THE BUCKLE." THE LAP-BAND SYSTEM REMAINS IMPLANTED AND SURGERY HAS NOT BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127563 -BAND ACCESS PORT KIT (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR LISINOPRIL