BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 1890212 · Received November 3, 2010

    Report

    Report Number
    3005992282-2010-00340
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 18, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DISPLACED. THE BAND/BALLOON WITH 50CM OF CATHETER, THE INJECTION PORT WITH THE LOCKING CONNECTOR AND THE TUBING STRAIN RELIEF WERE RETURNED FOR ANALYSIS. UPON VISUAL INSPECTION, BIOLOGICAL DEBRIS WAS OBSERVED AT ORIGINAL LOCATION OF THE TUBING STRAIN RELIEF. THEREFORE MIGRATION OF THE TUBING STRAIN RELIEF CAN BE CONFIRMED. THE STRAIN RELIEF WAS FLOATING ON THE CATHETER AT 42CM FROM THE LOCKING CONNECTOR. NO MARK OR DAMAGE WAS OBSERVED ON THE TUBING STRAIN RELIEF. HOWEVER, NO LINK CAN BE ESTABLISHED BETWEEN MOVEMENT OF THE STRAIN RELIEF AND LACK OF WEIGHT LOSS OF THE PATIENT. TO MITIGATE THE STRAIN RELIEF "MIGRATION" FROM THE LOCKING CONNECTOR, A DESIGN ENHANCEMENT HAS BEEN IMPLEMENTED (B)(4). IN ADDITION, (B)(4) ADJUSTABLE GASTRIC BAND AND REALIZE ADJUSTABLE GASTRIC BANDING PRODUCTS WITH THE PRE-ENHANCEMENT DESIGN WAS A VOLUNTARY RECALLED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND NO DISCREPANCIES WERE RECORDED 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, A LAPAROSCOPIC ADJUSTABLE BAND, THE PATIENT WAS NOT LOSING WEIGHT. FURTHER EVALUATION WAS DONE AND NO LEAK WAS FOUND. THE STRAIN RELIEF WAS FOUND TO HAVE MIGRATED DOWN FROM THE CONNECTION HOUSING ON THE BAND TUBING. ON (B)(6) 2010, THE PORT WAS REPLACED. THE PATIENT HAD 3-4 FILLS. THERE WAS NO ADVERSE PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REALIZE ADJ GASTRIC BAND-C IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK NI

    Patients

    Seq Age Sex Outcome Treatment
    1