BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

    MDR report key: 3965042 · Received July 29, 2014

    Report

    Report Number
    3005992282-2014-00044
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 11, 2014
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE VELOCITY PORT WAS RETURNED WITH DARK BIOLOGICAL DEBRIS AROUND THE BODY OF THE PORT. ONE HOOK APPEARS TO HAVE BEEN SEVERELY DAMAGED WITH THE HOOK BEING BENT OUT OF SHAPE. THE DEVICE COULD NOT BE MANUALLY ALTERED FROM THE LOCKED TO THE UNLOCKED POSITION. IN ADDITION, THE RLZB32 WAS RETURNED WITH THE BALLOON CUT IN TWO - NO TESTING NECESSARY. BALLOON CUT WITH THE CLOSED END STILL ATTACHED TO 49 CM OF CATHETER. LASTLY, A 5CM OF CATHETER IN SEPARATE PACKAGING ALONG WITH THE TUBING STRAIN RELIEF AND CONNECTOR. AT THE POINT OF EXPLANTATION, THE SURGEON STATED THAT THE PRODUCT DID NOT APPEAR DEFECTED. FUNCTIONAL TESTS WILL NOT BE PERFORMED AS ANALYSIS OF RETURNED DEVICE WOULD NOT ASSIST TO DETERMINING THE ROOT CAUSE OF THE REPORTED REFLUX & WEIGHT GAIN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BAND WAS REMOVED FROM THE PATIENT RELATED TO REFLUX AND WEIGHT GAIN. THE ORIGINAL SURGERY DATE WHEN THE BAND WAS PLACED IS UNKNOWN. A NEW BAND WAS NOT PLACED AND NO ADDITIONAL SURGICAL PROCEDURES WERE DONE. IT IS UNKNOWN WHAT TESTS WERE DONE ON THE PATIENT PRIOR TO THE BAND REMOVAL. THE BAND WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441309 IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ NA ZLBBGG

    Patients

    Seq Age Sex Outcome Treatment
    1