BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 2061101 · Received April 18, 2011

    Report

    Report Number
    3005992282-2011-00095
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 25, 2011
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE INJECTION PORT WITH LOCKING CONNECTOR WERE RETURNED FOR EVALUATION. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE ACTUATOR RING WAS IN UNLOCKED POSITION, HOOKS WERE RETRACTED. UPON MICROSCOPIC EVALUATION, IT WAS NOTED THAT THE SEPTUM WAS PUNCTURED 8 TIMES. A FUNCTIONAL TEST WAS PERFORMED ON THE INJECTION PORT WITH A SUCCESSFUL RESULT. HOOKS WERE DEPLOYED AND RETRACTED. DIMENSIONAL ANALYSIS OF THE RETURNED COMPONENTS WAS PERFORMED, ALL MEET SPECIFICATION. NOTE: THE TUBING STRAIN RELIEF WAS NOT RETURNED FOR EVALUATION. DEVICE WAS RETURNED FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-IMPLANT OF A REALIZE BAND,DURING A ROUTINE FILL, THE PA NOTICED THE TUBING WAS NOT CONNECTED. A PORT REVISION WAS PERFORMED RECONNECTING THE BAND TUBING TO A NEW PORT. THE LOCKING CONNECTOR WAS ATTACHED AND LOCKED. THE TUBING STRAIN RELIEF HAD MIGRATED OFF OF THE LOCKING CONNECTOR AND WAS EMBEDDED IN ADHESIONS BY THE FASCIA NEAR THE PORT. THE PATIENT IS OKAY.

    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 ZLFBHC

    Patients

    Seq Age Sex Outcome Treatment
    1