BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 2233186 · Received September 2, 2011

    Report

    Report Number
    3005992282-2011-00194
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 10, 2011
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE CONTACT. THE COMPLAINT CANNOT BE CONFIRMED. THE INJECTION PORT WITH THE LOCKING CONNECTOR AND TUBING STRAIN RELIEF WERE RETURNED FOR EVALUATION. THE RETURNED DEVICE WAS FULLY FUNCTIONAL. PORT MIGRATION/ROTATION IS A RECOGNIZED EVENT ASSOCIATED WITH THE REALIZE VELOCITY PORT. CONTRIBUTING FACTORS TO PORT DISPLACEMENT ARE OUTLINED WITHIN THE INSTRUCTIONS FOR USE ( IFU) AND INCLUDE PHYSICAL ACTIVITY OF THE PATIENT AND PORT LOCATION. UPON MICROSCOPIC INSPECTION IT WAS NOTED THAT PUNCTURES WERE OBSERVED ON THE TUBING STRAIN RELIEF. PRESENCE OF PUNCTURES ON THE TUBING STRAIN RELIEF IS PROBABLY THE RESULT OF A BAND ADJUSTMENT TECHNIQUE. TO MITIGATE THE STRAIN RELIEF "MIGRATION" FROM THE LOCKING CONNECTOR, A DESIGN ENHANCEMENT HAS BEEN IMPLEMENTED WITH THE APPROVAL OF THE FDA TO GLUE THE STRAIN RELIEF TO THE LOCKING CONNECTOR. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND NO DISCREPANCIES WERE RECORDED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE FILL UNDER FLUOROSCOPY, THE REALIZE INJECTION PORT WAS FLIPPED. THERE WAS NO INFORMATION ABOUT WHEN THE BAND WAS IMPLANTED OR HOW MANY FILLS THE PATIENT HAD RECEIVED. DURING THE PORT REVISION SURGERY, THE STRAIN RELIEF WAS NOT IN THE RIGHT LOCATION. THE PORT PLACEMENT WENT WELL WITH NO 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

    Patients

    Seq Age Sex Outcome Treatment
    1