BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 2183127 · Received July 28, 2011

    Report

    Report Number
    3005992282-2011-00162
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 18, 2011
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT POST IMPLANT OF THE REALIZE BAND, SHE WAS DOING FINE UNTIL (B)(6) 2011. SHE BEGAN EXPERIENCING NEUROPATHY IN HER HANDS AND LEGS AND HAS BILATERAL FOOT DROP. SHE IS ALSO UNSTEADY ON HER FEET AND HAS FALLEN THREE TIMES. SHE HAS OBSERVED THAT HER HAIR IS VERY BRITTLE. SHE FEELS THAT THIS IS RELATED TO A VITAMIN/NUTRITIONAL DEFICIENCY. A COMPLETE BLOOD COUNT TEST, COMPREHENSIVE METABOLIC PANEL AND LEVELS FOR THYMINE, FOLATE AND B12 WERE ORDERED. THE RESULTS SHOWED A DEFICIENCY IN THYMINE, IRON AND B12. THE PHYSICIAN HAS PRESCRIBED VITAMIN AND MINERAL SUPPLEMENTS AND B12 INJECTIONS. SHE IS CURRENTLY WEARING AFO BOOTS FOR BALANCE AND BILATERAL FOOT DROP. SHE ALSO INDICATED THAT SHE HAD GAINED FOUR POUNDS AT HER LAST FILL. SHE HAS HAD FOUR FILLS AND HAS 8CCS IN THE BAND AT THIS TIME. SHE FEELS THAT SHE IS NOT GETTING RESTRICTION. HOWEVER, IF SHE ATTEMPTS TO EAT MORE THAN 4 OZ, SHE FEELS TIGHTNESS. SHE STATED THAT THE FILLS ARE DONE UNDER X-RAY AND THE SURGEON REMOVES ALL THE FLUID PRIOR TO ADDING AND THERE IS NO INDICATION OF A LEAK. SINCE TAKING THE VITAMIN AND B12 INJECTIONS, SHE FEELS THAT THE SYMPTOMS ARE IMPROVING. SHE PLANS TO SEE A DIETICIAN FOR RECOMMENDED DIET TO ENSURE THAT SHE IS GETTING THE PROPER NUTRIENTS.

    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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other