BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 2992397 · Received March 1, 2013

    Report

    Report Number
    2024601-2013-00103
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    January 9, 2013
    Report Date
    February 4, 2013
    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

    (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 REC'D THE PRODUCT AT THIS TIME. THERE FORE NO ANALYSIS OR TESTING HAS BEEN DONE. INTOLERANCE IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE CONTRAINDICATION FOR PATIENTS REGARDING INTOLERANCE AS FOLLOWS: "IT IS IMPORTANT TO DISCUSS ALL POSSIBLE COMPLICATIONS AND ADVERSE EVENTS WITH YOUR PATIENT. 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 PATIENT'S DEGREE OF INTOLERANCE TO ANY FOREIGN OBJECT IMPLANTED IN THE BODY."

    Description of Event or Problem · 1

    HEALTH CARE PROFESSIONAL REPORTED THE REMOVAL OF A LAP-BAND SYSTEM FOR PT INTOLERANCE. THE DEVICE WILL BE RETURNED. FOLLOW-UP FINDINGS: NO FAILURE OF THE LAP-BAND SYSTEM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89115 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 2264426

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention MONOCOR| LOSEC| CLONAZEPAM