BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 1954140 · Received January 10, 2011

    Report

    Report Number
    3005992282-2011-00007
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 17, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPONENTS WERE RETURNED AS FOLLOWS: THE BAND/BALLOON WITH 1.5CM OF CATHETER. THE INJECTION PORT WITH LOCKING CONNECTOR, TUBING STRAIN RELIEF AND 53CM OF CATHETER. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT BUCKLE FROM THE BAND WAS CUT ON ONE SIDE (CUT PERFORMED DURING THE EXPLANTATION). SEVERAL BLOOD AND TISSUE SPOTS WERE ON BAND AND BALLOON. THE INJECTION PORT WAS RETURNED IN LOCKED POSITION, ALL HOOKS WERE RETURNED DEPLOYED. BIOLOGICAL DEBRIS WERE OBSERVED INSIDE OF HOOKS AND ACTUATOR RING. PER VISUAL MICROSCOPIC INSPECTION IT WAS NOTED THAT THE SEPTUM WAS PUNCTURED 9 TIMES. EVALUATION OF THE DEVICE CANNOT CONFIRM EVENTS THAT ARE PHYSIOLOGICAL IN NATURE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT OF A REALIZE GASTRIC BAND, THE BAND SLIPPED. THIS WAS DETECTED BY AND UPPER GI X-RAY ON (B)(6), 2010. THE BAND WAS REPLACED AND WAS DISCHARGED HOME SAME DAY. THERE WERE NO REPORTED COMPLICATIONS.

    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 ZJJBLL

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention