BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND SYSTEM ACCESS PORT II KIT

    MDR report key: 2152461 · Received June 28, 2011

    Report

    Report Number
    2024601-2011-00544
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    January 2, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON: (B)(4) 2011. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. 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

    A PT REPORTED: THE PORT HAS "LOST ALL THE FLUID" AND "WOULD NOT FILL AND NO FLUID COULD BE TAKEN FROM THE PORT." FOLLOW UP MEDICAL PAPERWORK FROM THE PHYSICIAN STATES THAT THE PT "HAS FELT NO RESTRICTION FOR 3 MONTHS." THE "FLUID LEVEL IS LOWER" AT ADJUSTMENTS AND THE SURGEON WAS UNABLE TO "PULL ANY FLUID BACK." EXPLANT SURGERY IS PENDING AT THIS TIME. THE SURGEON WILL NOTIFY ALLERGAN WHEN EXPLANT SURGERY HAS BEEN SCHEDULED FOR THIS PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND SYSTEM ACCESS PORT II KIT LTI ALLERGAN NA 1651031

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR