BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND SYSTEM ACCESS PORT I KIT

    MDR report key: 1881963 · Received October 12, 2010

    Report

    Report Number
    2024601-2010-00793
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    April 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: (B)(4) 2010. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT BEEN RETURNED. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE RPTR THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE RPTR OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION COULD CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. PER THE SURGEON'S OFFICE, THE DEVICE REMAINS IN THE PT'S POSSESSION. 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

    HEALTH PROFESSIONAL CALLED AND REPORTED AN "ALLEGED" PORT LEAK. THE PT WAS "NOT FEELING RESTRICTION" FROM THEIR LAP-BAND DEVICE SO A "CALIBRATION WAS PERFORMED." RESULTS "INDICATED LESS SALINE THAN WAS INJECTED DURING A FILL PERFORMED THE WEEK PRIOR." THE PORT WAS REPLACED AND GIVEN TO THE PT. IT IS NOT BEING RETURNED TO ALLERGAN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND SYSTEM ACCESS PORT I KIT LTI ALLERGAN NA 1830654

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR