BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDIN SYSTEM (LARGE)

    MDR report key: 2914888 · Received January 10, 2013

    Report

    Report Number
    2024601-2012-01391
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    October 18, 2009
    Report Date
    July 27, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENT #1 - MEDWATCH SENT TO FDA ON 02/12/2016.

    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. ABDOMINAL PAIN IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF ABDOMINAL 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

    DOCTOR REPORTED PATIENT IN HERO STUDY EXPERIENCED ABDOMINAL PAIN WITH HOSPITALIZATION OCCURRING. IT WAS RESOLVED WITHOUT SEQUELAE. THE LAP-BAND SYSTEM REMAINS IMPLANTED.

    Description of Event or Problem · 1

    NEW/UPDATED INFORMATION HAS BEEN PROVIDED BY THE PHYSICIAN FOR A PATIENT IN THE (B)(6) CLINICAL STUDY. THE REPORTED EVENT OF ABDOMINAL PAIN HAS BEEN FOUND TO BE NOT DEVICE RELATED AND NOT PROCEDURE RELATED. THE ADDITIONAL EVENT DESCRIPTION WAS PROVIDED AS "[THE PATIENT] WENT TO ER IN SEVERE ABDOMINAL PAIN. PAIN MEDS AND IV FLUIDS FOR TREATMENT." THE PATIENT WAS ADMITTED TO THE HOSPITAL AND DISCHARGED AFTER TWO DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15004 LAP-BAND AP ADJUSTABLE GASTRIC BANDIN SYSTEM (LARGE) LTI ALLERGAN NA 1755216

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization