BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT

    MDR report key: 1845026 · Received September 27, 2010

    Report

    Report Number
    3005992282-2010-00290
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    June 20, 2010
    Report Date
    August 31, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. PORT REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PORT IMPLANT A (B)(4) ADJUSTABLE GASTRIC BANDING PROCEDURE, CONTRAST STUDY THAT SHOWED A LEAK FROM THE PORT NOT FROM THE TUBING. THIS IS CAUSING THE BAND TO DEFLATE. THE SURGEON PLANS TO REPLACE THE OLD PORT WITH A NEW PORT. ADDITIONAL FOLLOW UP IS BEING CONDUCTED. IF ADDITIONAL DETAILS BECOME AVAILABLE A 3500 A SUPPLEMENTAL WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1