BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 3940171 · Received March 21, 2014

    Report

    Report Number
    2024601-2014-00124
    Event Type
    Injury
    Date Received
    March 21, 2014
    Date of Event
    February 21, 2014
    Report Date
    February 27, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. ALLERGAN HAS RECEIVED THE PRODUCT, HOWEVER, THE DEVICE HAS NOT BEEN IDENTIFIED NOR HAS THE ANALYSIS BEEN COMPLETED AT THIS TIME. BASED UPON THE MODEL 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. ALLERGAN HAS RECEIVED THE PRODUCT, HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF EROSION AS FOLLOWS: "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 ELECTRO-CAUTERY, 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.: DEVICE LABELING ADDRESSES THE REPORTED EVENT OF IRRITATION/INFLAMMATION AS FOLLOWS: "CONTRAINDICATIONS: THE LAP-BAND SYSTEM IS CONTRAINDICATED IN: 1. PATIENTS WITH INFLAMMATORY DISEASES OF THE GASTROINTESTINAL TRACT, INCLUDING SEVERE INTRACTABLE ESOPHAGITIS, GASTRIC ULCERATION, DUODENAL ULCERATION, OR SPECIFIC INFLAMMATION SUCH AS CROHN'S DISEASE." 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 OCCURED IN FEWER THAN 1% OF SUBJECTS INCLUDED: ABDOMINAL PAIN, CHEST PAIN, INCISION PAIN AND PORT SITE PAIN."

    Description of Event or Problem · 1

    HEALTHCARE PROFESSION REPORTED A LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM "ERODING INTO THE STOMACH WITH EXTENSIVE REGIONAL INFLAMMATORY RESPONSE AND THE PATIENT [EXPERIENCED] ABDOMINAL PAIN." THE LAP-BAND SYSTEMS WAS EXPLANTED, BUT NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168328 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention