BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 4173504 · Received October 10, 2014

    Report

    Report Number
    2024601-2014-00573
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    April 15, 2012
    Report Date
    September 17, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECT 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. PORT SITE PAIN, REFLUX, NAUSEA AND VOMITING ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. NO ADDITIONAL INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OR CONFIRMATION OF THE OTHER EVENTS OR TREATMENT OF THEM.

    Description of Event or Problem · 1

    PT REPORTED A PORT "LEAK" WITH THEIR LAP-BAND SYSTEM. THE PROBLEM WAS FIRST NOTICED WHEN THE PT WAS "GAINING WEIGHT AND THERE WAS NO RESTRICTION." THE PT ALSO REPORTED EXPERIENCING PAIN, NAUSEA, VOMITING, AND REFLUX. THE PT ALSO STATED THAT ADJUSTMENT FILLS WERE UNSUCCESSFUL AND THE SALINE "WASN'T HOLDING." THE PORT OF THE LAP-BAND SYSTEM WAS REMOVED AND REPLACED AND THE BRAND REMAINS IMPLANTED. THE LEAK HAS BEEN CONFIRMED BY MEDICAL HEALTHCARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642936 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR EFFEXOR