BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2230625 · Received August 12, 2011

    Report

    Report Number
    2024601-2011-00673
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    November 17, 2010
    Report Date
    July 18, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: 8/12/2011. THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE REPORTER DID NOT KNOW THE STATUS OF THE EXPLANTED DEVICE AND WILL NOT PROVIDE THE CONTACT INFO FOR THE EXPLANT SURGEON. THEREFORE ALLERGAN WILL NOT BE ABLE TO F/U AND REQUEST THE RETURN OF THE DEVICE AND NO ANALYSIS OR TESTING WILL BE DONE. THE TGA REPORT STATED THAT DUE TO THE CONFIDENTIALITY REQUESTED BY THE REPORTER TO THEIR AGENCY, THEY ARE NOT ABLE TO PROVIDE ALLERGAN WITH ANY IDENTIFYING DETAILS TO PURSUE THE INVESTIGATION AND THAT IT IS CLOSED. DEVICE LABELING ADDRESSES THE POSSIBILITY OF BREAKAGE AS FOLLOWS: THE MFR OF THE LAP-BAND ADJUSTABLE GASTRIC BANDING SYS HAS DESIGNED, TESTED AND MFG IT TO BE REASONABLY FIT FOR ITS INTENDED USE. HOWEVER, THE LAP-BAND SYS IS NOT A LIFETIME PRODUCT AND IT MAY BREAK OR FAIL, IN WHOLE OR IN PART, AT ANY TIME AFTER IMPLANTATION AND NOTWITHSTANDING THE ABSENCE OF ANY DEFECT. CAUSES OF PARTIAL OR COMPLETE FAILURE INCLUDE, WITHOUT LIMITATION, EXPECTED OR UNEXPECTED BODILY REACTIONS TO THE PRESENCE AND POSITION OF THE IMPLANTED DEVICE, RARE OR ATYPICAL COMPLICATIONS, COMPONENT FAILURE AND NORMAL WEAR AND TEAR. IN ADDITION, THE LAP-BAND SYS MAY BE EASILY DAMAGED BY IMPROPER HANDLING OR USE. PLEASE REFER TO THE ADVERSE SECTION IN THIS DOCUMENT AND TO THE INFO FOR PTS BOOKLET FOR A PRESENTATION OF THE WARNINGS, PRECAUTIONS, AND THE POSSIBLE ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE LAP-BAND ADJUSTABLE GASTRIC BANDING SYS. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF PAIN AS FOLLOWS: CONTRAINDICATIONS: "THE LAP-BAND SYS IS CONTRAINDICATED IN: PTS WHO ARE KNOWN TO HAVE, OR SUSPECTED TO HAVE, AN ALLERGIC REACTION TO MATERIALS CONTAINED IN THE SYS OR WHO HAVE EXHIBITED PAIN INTOLERANCE TO IMPLANTED DEVICES." WARNINGS: "PTS MUST BE CAREFULLY COUNSELED ON THE NEED TO REPORT ALL VOMITING, ABDOMINAL PAIN OR OTHER GASTROINTESTINAL OR NUTRITIONAL ISSUES AS THESE SYMPTOMS MAY INDICATE A CONDITION NOT RELATED TO THE LAP-BAND SYS." ADVERSE EVENTS: "SLIPPAGE AND/OR POUCH DILATATION OF THE BAND CAN OCCUR. GASTROESOPHAGEAL REFLUX, NAUSEA AND/OR VOMITING WITH EARLY OR MINOR SLIPPAGE MAY BE IN SOME CASES SUCCESSFULLY RESOLVED BY BAND DEFLATION. MORE SERIOUS SLIPPAGES MAY REQUIRE BAND REPOSITIONING AND/OR REMOVAL. IF THERE IS TOTAL STOMA OUTLET OBSTRUCTION THAT DOES NOT RESPOND TO BAND DEFLATION, OR IF THERE IS ABDOMINAL PAIN, THEN IMMEDIATE RE-OPERATION TO REMOVE THE BAND IS INDICATED." "THERE IS A RISK OF BAND EROSION INTO STOMACH TISSUE. EROSION OF THE BAND INTO STOMACH TISSUE HAS BEEN ASSOCIATED WITH REVISION SURGERY, AFTER THE USE OF GASTRIC-IRRITATING MEDICATIONS, AFTER STOMACH DAMAGE AND AFTER EXTENSIVE DISSECTION OR USE OF ELECTROCAUTERY, AND DURING EARLY EXPERIENCE. SYMPTOMS OF BAND EROSION MAY INCLUDE REDUCED WEIGHT LOSS, WEIGHT GAIN, ACCESS PORT INFECTION, OR ABDOMINAL PAIN. RE-OPERATION TO REMOVE THE DEVICE IS REQUIRED." "INTL DATA SUGGESTS HYPER-INSULINEMIA, INSULIN RESISTANCE AND DISEASE ASSOCIATED WITH INSULIN RESISTANCE, POOR PHYSICAL ACTIVITY, PAIN AND POOR GENERAL HEALTH RESPONSES TO THE SF-36 HEALTH SURVEY ARE ASSOCIATED WITH A SLOWER WEIGHT LOSS. STEPS FOR PERFORMING ADJUSTMENT: LOCAL ANESTHESIA MAY BE USED TO ELIMINATE PAIN DURING INJECTION." DEVICE LABELING ADDRESSES THE POTENTIAL OF ADVERSE EVENTS AS FOLLOWS: "IT IS IMPORTANT TO DISCUSS ALL POSSIBLE COMPLICATIONS AND ADVERSE EVENTS WITH YOUR PT. COMPLICATIONS WHICH MAY RESULT FROM THE USE OF THIS PRODUCT INCLUDE THE RISKS ASSOCIATED WITH THE MEDICATIONS AND METHODS UTILIZED IN THE SURGICAL PROCEDURE, THE RISKS ASSOCIATED WITH ANY SURGICAL PROCEDURE AND THE PT'S DEGREE OF INTOLERANCE TO ANY FOREIGN OBJECT IMPLANTED IN THE BODY." "CAUTION: IT IS THE RESPONSIBILITY OF THE SURGEON TO ADVISE THE PT OF THE KNOWN RISKS AND COMPLICATIONS ASSOCIATED WITH THE SURGICAL PROCEDURE AND IMPLANT." "CAUTION: PTS MUST BE SEEN REGULARLY DURING PERIODS OF RAPID WEIGHT LOSS FOR SIGNS OF MALNUTRITION, ANEMIA OR OTHER RELATED COMPLICATIONS." "ADVERSE EVENTS: PERFORATION OF THE STOMACH CAN OCCUR. DEATH CAN ALSO OCCUR. SPECIFIC COMPLICATIONS OF LAPAROSCOPIC SURGERY CAN INCLUDE SPLEEN DAMAGE (SOMETIMES REQUIRING SPLENECTOMY) OR LIVER DAMAGE, BLEEDING FROM MAJOR BLOOD VESSELS, LUNG PROBLEMS, THROMBOSIS, AND RUPTURE OF THE WOUND." "AS WITH OTHER SURGICAL DECISIONS, IT IS THE RESPONSIBILITY OF THE SURGEON TO USE HIS OR HER OWN JUDGMENT IN UTILIZING THE PROCEDURES BEST SUITED TO THE NEEDS OF THE PT AND THE SKILL AND EXPERIENCE OF THE SURGEON. DETAILED PRESENTATIONS OF SPECIFIC PROCEDURES HAVE BEEN PUBLISHED. THESE PUBLICATIONS AND ADD'L INFO REGARDING PROCEDURES ARE PROVIDED IN ALLERGAN AUTHORIZED LAP-BAND SYS TRAINING PROGRAMS."

    Description of Event or Problem · 1

    EVENT REPORTED BY THE THERAPEUTIC GOODS ADMINISTRATION (TGA) AS, "A PT SUFFERED A FAILING OF ADJUSTABLE GASTRIC BANDING SYS AS INSERTED BY DR. THE BROKEN LAP-BAND WAS REMOVED THROUGH EMERGENCY SURGERY, AND AS A RESULT THE PT REQUIRED BOTH INTERNAL AND EXTERNAL STITCHES FOR THAT SURGERY. FURTHERMORE THE PT SUFFERED UNNECESSARY PAIN AND STRESS ASSOCIATED WITH THAT SURGERY AS DR DID NOT SATISFACTORY CLOSE THE WOUND AFTER THE REMOVAL OF THE LAP-BAND." "PT OUTCOME SATISFACTORY." THE REPORTER REQUESTED TO REMAIN CONFIDENTIAL AND SO ALLERGAN WILL NOT BE ABLE TO CONDUCT ANY ADD'L INVESTIGATION INTO THIS REPORTED EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention