BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AP STANDARD RAPID-PORT EZ

    MDR report key: 3001960 · Received March 11, 2013

    Report

    Report Number
    2024601-2013-00131
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Date of Event
    December 11, 2012
    Report Date
    February 12, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A RAPIDPORT EZ STRAIN RELIEF. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. INADEQUATE WEIGHT LOSS IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF INADEQUATE WEIGHT LOSS AS FOLLOWS: "CAUTION: INSUFFICIENT WEIGHT LOSS MAY BE A SYMPTOM OF INADEQUATE RESTRICTION (BAND TOO LOOSE). OR, IT MAY BE A SYMPTOM OF POUCH OR ESOPHAGEAL ENLARGEMENT, AND MAY BE ACCOMPANIED BY OTHER SYMPTOMS, SUCH AS HEARTBURN, REGURGITATION OR VOMITING. IF THIS IS THE CASE, INFLATION OF THE BAND WOULD NOT BE APPROPRIATE."

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED A LAP-BAND SYSTEM EXPLANT DUE TO A "DEFECTIVE LAP-BAND." IT WAS NOTED THAT "PATIENT WAS NOT LOSING WEIGHT" AND A LEAK WAS NOTED IN THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102091 AP STANDARD RAPID-PORT EZ LTI ALLERGAN NA 2136188

    Patients

    Seq Age Sex Outcome Treatment
    1 NI