BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ACCESS PORT KIT (UNK SIZE)

    MDR report key: 1931721 · Received November 22, 2010

    Report

    Report Number
    2024601-2010-00933
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    March 10, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON: (B)(4) 2010. THE PRODUCT ASSOCIATED WITH THIS REPORT WAS DISCARDED POST-OPERATIVELY AND WILL NOT BE RETURNED FOR ANALYSIS. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. ALLERGAN HAS NOT RECEIVED THE PRODUCT. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. NO ADD'L INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OF THE DEVICE. 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

    MEDICAL STAFF REPORTED THAT THE ACCESS PORT TO A LAP-BAND DEVICE WAS LEAKING. FOLLOW-UP FINDINGS: THE PROBLEM WAS FIRST OBSERVED, PRIOR TO EXPLANT WHEN THE PT HAD "INCREASING HUNGER, LOSS OF RESTRICTIVE SYMPTOMS" DURING A "SERIES OF FULL FLUID ASPIRATIONS." THE PORT WAS REPLACED. THE EXPLANTED DEVICE WAS DISCARDED AND WILL NOT BE RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR NONE REPORTED.