BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2940944 · Received January 16, 2013

    Report

    Report Number
    2024601-2012-01393
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    November 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALLERGAN HAS RECEIVED THE PRODUCT HOWEVER THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A RAPIDPORT EZ STRAIN RELIEF. NO ADDITIONAL INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OR MODEL NUMBER. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF DISPLACEMENT AS FOLLOWS: "CAUTION: "CARE MUST BE TAKEN TO PLACE THE ACCESS PORT IN A STABLE POSITION AWAY FROM AREAS THAT MAY BE AFFECTED BY SIGNIFICANT WEIGHT LOSS, PHYSICAL ACTIVITY, OR SUBSEQUENT SURGERY. FAILURE TO DO SO MAY RESULT IN THE INABILITY TO PERFORM PERCUTANEOUS BAND ADJUSTMENTS. ACCESS PORTS HAVE BEEN REPORTED TO BE "FLIPPED" OR INVERTED. IF YOU INITIALLY SEEN AN OBLIQUE OR SIDE VIEW ON X-RAY, THEN EITHER REPOSITION THE PT OR THE X-RAY EQUIPMENT UNTIL YOU OBTAIN A PERPENDICULAR, OVERHEAD (0 DEGREE) VIEW. TARGETING THE PORT FOR NEEDLE PENETRATION CAN BE DIFFICULT IF THIS ORIENTATION IS NOT CONTROLLED. BE AWARE THAT AN UPSIDE DOWN (180 DEGREE) PORT SHOWS THE SAME IMAGE."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED THE EXPLANT AND REPLACEMENT OF A LAP BAND PORT DUE TO A PORT DISPLACEMENT FIRST NOTICE WHEN THE PHYSICIAN WAS UNABLE TO ACCESS THE PORT DURING AN ADJUSTMENT FILL. THE PORT HAD PREVIOUSLY BEEN REVISED TO CORRECT AND REFASTEN THE DISPLACED PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25153 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR CALCIUM| SYNTHROID| VITAMIN D