BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2960525 · Received February 12, 2013

    Report

    Report Number
    2024601-2013-00060
    Event Type
    Injury
    Date Received
    February 12, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 9, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RESUTURED AND REMAINS IMPLANTED. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS EITHER A TAPER I OR TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. PAIN, DISPLACEMENT, AND VISIBILITY/PALPABILITY ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF DISPLACEMENT AND VISIBILITY/PALPABILITY 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." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF PAIN AS FOLLOWS: "THERE WERE ADDITIONAL OCCURRENCES OF THESE EVENTS THAT WERE CONSIDERED TO BE NON-SERIOUS. OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYSTEM THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED: ABDOMINAL PAIN, CHEST PAIN, INCISION PAIN AND PORT SITE PAIN."

    Description of Event or Problem · 1

    PATIENT REPORTED A LAP-BAND SYSTEM ACCESS PORT THAT "HAS FLIPPED" AND IS "PAINFUL" WITH DOCTOR STATING THE TUBING IS COMING UP." EVENT WAS FIRST NOTICED WHEN PATIENT COMPLAINED OF 'WEIRD MOVEMENT IN THE STOMACH." DEVICE REMAINS IMPLANTED. FOLLOW-UP INFORMATION: HEALTHCARE PROFESSIONAL STATED THE PHYSICIAN "FEELS LIKE PORT IS ROTATING VERTICALLY" AND IS "BULGING OUT AND YOU CAN PUSH IT BACK IN." FOLLOW-UP INFORMATION: HEALTH PROFESSIONAL REPORTED THE PORT WAS REATTACHED TO THE PATIENT'S "MUSCLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60726 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention