BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    MDR report key: 1970289 · Received January 14, 2011

    Report

    Report Number
    2024601-2010-01077
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 22, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. 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. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. EROSION AND ABDOMINAL PAIN 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 PAIN AS FOLLOWS: "WARNINGS PATIENTS 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 SYSTEM." 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."

    Description of Event or Problem · 1

    EVENT REPORTED AS A BAND EROSION. GASTROSCOPE DONE BY FAMILY DOCTOR CONFIRMED EROSION. THE APS LAP-BAND SYSTEM WAS REMOVED AND WILL BE RETURNED. FOLLOW-UP FINDINGS: PHYSICIAN'S NURSE REPORTED THAT THE PT WAS SEEN FOR ABDOMINAL PAIN INITIALLY. THE PT HAD A GALL-BLADDER REMOVAL THREE MONTHS PRIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) LTI ALLERGAN NA 1748385

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention