BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 3020592 · Received March 21, 2013

    Report

    Report Number
    2024601-2013-00191
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    January 31, 2008
    Report Date
    March 7, 2008
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT REMAINS IMPLANTED AT THIS TIME. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. PORT DISPLACEMENT, PORT SITE PAIN, AND ABDOMINAL ADHESIONS. 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 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." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF ADHESIONS AS FOLLOWS: GASTRIC BANDING DONE AS A REVISION PROCEDURE HAS A GREATER RISK OF COMPLICATIONS. PRIOR ABDOMINAL SURGERY IS COMMONLY ASSOCIATED WITH ADHESIONS INVOLVING THE STOMACH. IN THE UNITED STATES PIVOTAL STUDY OF SEVERELY OBESE ADULTS, 42% OF THE SUBJECTS UNDERGOING REVISION SURGERY WERE REPORTED TO HAVE ADHESIONS INVOLVING THE STOMACH. CARE AND TIME MUST BE TAKEN TO ADEQUATELY RELEASE THE ADHESIONS TO PROVIDE ACCESS, EXPOSURE AND MOBILIZATION OF THE STOMACH FOR A REVISION PROCEDURE."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED PT IN (B)(4) STUDY EXPERIENCED A FLIPPED PORT, PORT SITE PAIN, AND ABDOMINAL ADHESIONS. REVISION OF PORT WITH MESH FIXATION AND LYSIS OF ABDOMINAL ADHESIONS OCCURRED ON (B)(6) 2008 TO TREAT EVENTS. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117178 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1468408

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention