BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 1973974 · Received January 31, 2011

    Report

    Report Number
    3005992282-2011-00028
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    September 8, 2010
    Report Date
    January 12, 2011
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). TEAR. CORRECTED DATA: COMPONENTS WERE RETURNED AS FOLLOWS: THE STRAIGHT BAND/BALLOON WITH 37CM OF CATHETER. THE INJECTION PORT WITH LOCKING CONNECTOR. THE TUBING STRAIN RELIEF. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE BUCKLE FROM THE BAND WAS RETURNED CUT ON ONE SIDE (PROBABLY PERFORMED DURING THE EXPLANT), A TEAR OF 2.3MM IN LENGTH AND LOCALIZED AT 3.5CM FROM THE CATHETER CONNECTION WAS ALSO OBSERVED ON THE BALLOON. THE INJECTION PORT WAS RETURNED COVERED OF BIOLOGICAL DEBRIS. THE ACTUATOR RING WAS IN LOCKED POSITION, AND HOOKS WERE DEPLOYED. THE LOCKING CONNECTOR WAS IN LOCKED POSITION. A LEAK TEST WAS PERFORMED ON THE BALLOON WITH UNSUCCESSFUL RESULTS, LEAK WAS FOUND, WHERE TEAR WAS OBSERVED. A BLOCKAGE TEST WAS PERFORMED ON THE INJECTION PORT WITH A SUCCESSFUL RESULT; NO BLOCKAGE WAS FOUND. A LEAK TEST WAS PERFORMED ON THE INJECTION PORT WITH SUCCESSFUL RESULT; NO LEAK WAS FOUND. BIOLOGICAL DEBRIS WAS MANUALLY REMOVED AND A FUNCTIONAL TEST WAS PERFORMED ON THEN INJECTION PORT WITH A SUCCESSFUL RESULT, HOOKS WERE DEPLOYED AND RETRACTED. DIMENSIONAL ANALYSIS AROUND THE TUBING CONNECTION WAS PERFORMED, ALL MEASUREMENTS ARE MEET SPECIFICATION. THE REPORTED EVENT COULD NOT BE CONFIRMED THE INJECTION PORT WAS FULLY FUNCTIONAL. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BAND/BALLOON RETURNED FOR INVESTIGATION AND FINAL PACKAGING LOT, AND NO DISCREPANCIES WERE RECORDED DURING THE MANUFACTURING PROCESS IN RELATION TO THE ALLEGED ISSUE. IT WAS ALSO NOTED THAT 100% OF ALL DEVICES ARE LEAK TESTED PRIOR TO LOT RELEASE; THEREFORE IT IS UNLIKELY THAT MANUFACTURE PROCESS CONTRIBUTE AT THIS EVENT DESCRIPTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INITIAL PROCEDURE WENT WELL IN (B)(6) 2010. THE PATIENT HAD LOST (B)(6) AND THEN STOPPED LOSING WEIGHT. A FILL WAS DONE UNDER FLUOROSCOPY AND IT WAS NOTICED THAT THE FLUID WAS COMING OUT AROUND THE PORT, BUT IT IS UNKNOWN EXACTLY WHERE. THE SURGEON PLANS TO PERFORM A PORT REVISION PROCEDURE. 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 REALIZE ADJ GASTRIC BAND STR IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK ZJGBHK

    Patients

    Seq Age Sex Outcome Treatment
    1