BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM WITH RAPIDPORT

    MDR report key: 3202044 · Received June 27, 2013

    Report

    Report Number
    2024601-2013-00566
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    March 22, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS IF IT IS EXPLANTED IN THE FUTURE. THE DEVICE WAS RESUTURED INTO PLACE AND REMAINS IMPLANTED. BASED UPON THE MODEL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A RAPIDPORT EZ STRAIN RELIEF. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS, IF IT IS EXPLANTED IN THE FUTURE. IT WAS REPOSITIONED DURING THE PROCEDURE AND ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. 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 SEE AN OBLIQUE OR SIDE VIEW ON X-RAY, THEN EITHER REPOSITION THE PT OR THE X-RAY EQUIPMENT UNTIL YOU OBTAIN A PERPENDICULAR, OVERHEAD (ZERO DEGREE) VIEW. TARGETING THE PORT FOR NEEDLE PENETRATION CAN BE DIFFICULT IF THIS ORIENTATION IS NOT CONTROLLED." "CAUTION: THE ACCESS PORT MUST BE SECURELY FASTENED TO THE PT'S RECTUS FASCIA WITH ALL FOUR OF THE STAINLESS STEEL ANCHORS FIRMLY EMBEDDED IN THE PT'S FASCIA. IF THIS IS NOT ACHIEVED, THE ACCESS PORT MAY BECOME LOOSE AND INACCESSIBLE FOR POST-OPERATIVE ADJUSTMENTS, THUS REQUIRING REVISIONAL SURGERY."

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THIS PT WITH A RPEZ PORT THAT IS FLIPPED AND HAVE TO BE REPAIRED/RE-FIXATED. INVESTIGATION IN PROGRESS. F/U FINDINGS: ACCESS PORT HAD FLIPPED 180 DEGREES. COULD NOT ACCESS LAP-BAND ACCESS PORT DURING ROUTINE CLINIC VISIT, PT SENT TO X-RAY AND PORT FLIP IDENTIFIED. LAPAROTOMY TO RE-ATTACH PORT TO ABDOMINAL RECTUS SHEATH. TACKS WERE DEPLOYED BUT NOT ATTACHED TO RECTUS SHEATH. PER THE COMPANY REP, "THE SURGEON ALWAYS TESTS FOR SECURITY OF THE PORT FIXATION AT TIME OF IMPLANT." THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293130 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM WITH RAPIDPORT LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR