BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPATZ3 ADJUSTABLE BALLOON SYSTEM

    MDR report key: 15876381 · Received November 29, 2022

    Report

    Report Number
    3012638928-2022-02472
    Event Type
    Injury
    Date Received
    November 29, 2022
    Date of Event
    September 28, 2022
    Report Date
    November 29, 2022
    Manufacturer
    TRUE YOU WEIGHT LOSS (ATLANTA)
    Product Code
    LTI
    UDI-DI
    860005178803
    PMA / PMN Number
    P190012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BALLOON WAS NOT RETURNED FOR EXAMINATION. THE BALLOON WAS INTACT AS THE CASE WAS AS A RESULT OF INTOLERANCE. A REVIEW OF THE DEVICE LABELING NOTES THE FOLLOWING: THE PHYSICIAN SHOULD ALSO ADVISE THE PATIENT THAT EARLY REMOVAL OF THE BALLOON MAY BE REQUIRED DUE TO INTOLERANCE OR DUE TO SERIOUS ADVERSE EVENTS. IT IS THE RESPONSIBILITY OF THE PHYSICIAN TO ADVISE THE PATIENT OF THE POTENTIAL NEED TO REMOVE THE DEVICE IN LESS THAN 8 MONTHS DUE TO BALLOON DEFLATION. IN THE EVENT OF GASTROINTESTINAL INTOLERANCE, THE PHYSICIAN MAY ADVISE THE PATIENT TO DECREASE BALLOON VOLUME. IT IS IMPORTANT TO DISCUSS ALL POSSIBLE COMPLICATIONS AND ADVERSE EVENTS WITH THE PATIENT. COMPLICATIONS THAT MAY RESULT FROM USE OF THIS PRODUCT INCLUDE THOSE ASSOCIATED WITH GENERAL ENDOSCOPY PROCEDURES, THOSE ASSOCIATED WITH THE SPATZ3 ADJUSTABLE BALLOON SPECIFICALLY AND THOSE ASSOCIATED WITH THE PATIENT'S DEGREE OF INTOLERANCE TO AN IMPLANTED FOREIGN BODY. ADVERSE HEALTH CONSEQUENCES RESULTING FROM WEIGHT LOSS SUCH AS GALLSTONES, DEHYDRATION, LOSS OF MUSCLE MASS, MOOD CHANGES, ELECTROLYTE ABNORMALITIES, MENSTRUAL CHANGES AND NUTRITIONAL DEFICIENCIES. ACUTE PANCREATITIS CHARACTERIZED BY NAUSEA, VOMITING, ABDOMINAL PAIN, DEHYDRATION. THE SEVERITY CAN RANGE FROM MILD TO SEVERE AND MAY REQUIRE BALLOON DOWN ADJUSTMENT, OR REMOVAL. THIS MAY RESULT IN HOSPITALIZATION, SURGERY OR DEATH IN SEVERE CASES. ADDITIONAL INFORMATION REGARDING THIS LATE MEDWATCH REPORT- THE FIRM WAS NOT AWARE THAT REPORTS REPORTED TO FDA UNDER CLINICAL SETTING SHOULD ALSO BE REPORTED AS A MEDWATCH REPORT. CAPA WAS ISSUED AND PROCEDURES WERE UPDATED, AND QA DEP. WAS RETRAINED.

    Description of Event or Problem · 0

    (B)(6) 2022: PATIENT INFORMED STUDY PL ON (B)(6) 2022 THAT SHE WAS HOSPITALIZED FOR FATIGUE AND ELECTROLYTE DERANGEMENTS (HYPOKALEMIA. HYPOMAGNESEMIA. AND HYPOPHOSPHATEMIA) STARING ON (B)(6) 2022. PATIENT INFORMED STUDY PL WOULD BE GETTING DISCHARGED ON (B)(6) 2022. PL SUSPECTS PATIENT MAY HAVE SUSTAINED RE-FEEDING SYNDROME. PATIENT COURSE OF EVENTS INCLUDE THE FOLLOWING: PLACEMENT (B)(6) 2022, 450 ML, PUSHED THROUGH NAUSEA/ABDOMINAL PAIN/BLOATING (B)(6) 2022. SIGNIFICANT DIFFICULTY GETTING LIQUIDS IN FOR FIRST WEEK LEADING 10 SIGNS OF DEHYDRATION, SUPPORTED WITH VISITS TO HYDRATION CLINIC AT SITE 31. GIVEN INABILITY TO ADVANCE DIET, DECREASED VOLUME BY 100 ML, ON (B)(6) 2022 (RATHER THAN PER-PROTOCOL 150 ML, WHICH LOOKED TOO DEFLATED UPON INSPECTION; PD FILED). SYMPTOMS IMPROVED IMMEDIATELY POST-PROCEDURALLY. HOSPITALIZATION OCCURRED ONE WEEK LATER (B)(6) 2022. THE PATIENT IS DOING WELL NOW. STUDY SITE WAITING TO RECEIVE HOSPITALIZATION PAPERWORK AND CONFIM1ATION OF DISCHARGE FROM PATIENT. GIVEN HER COURSE. AND RECENT HOSPITALIZATION, THE STUDY PL AGREES WITH HER HOSPITAL TEAM THAT THE BALLOON SHOULD BE REMOVED. BALLOON REMOVAL SCHEDULED FOR(B)(6) 2022. STUDY STAFF WILL CONTINUE TO UPDATE SPONSOR AS MORE INFORMATION IS RECEIVED AND FOLLOWING BALLOON REMOVAL. (B)(6) 2022: PATIENT HAD HYDRATION VISIT AT SITE 31 ON (B)(6) 2022. VITAL SIGNS WERE STABLE, AND SHE TOLERATE I L OF LR AND BAD A DOSE OF ZOFRAN FOROAUSCA. PATIENT REPORTED RELIEF OF NAUSEA AT THE END OF HER INFUSION. PATIENT ALSO PROVIDED ADDITIONAL UPDATE REGARDING HOSPITALIZATION TO PL ON (B)(6) 2022. SHE REPORTED SHE HAD A COLD FOR THE 2 DAYS PRIOR TO HER HOSPITALIZATION WITH ASSOCIATED REDUCED PO INTAKE. WHEN SHE WAS WALKING UP U1E STAIRS FROM HER BASEMENT, SHE PASSED OUT AND WAS LATER FOUND BY HER SON ON (B)(6) 2022. NO INJURIES BESIDES A SORE LEFT ARM REPONED. THE PATIENT WENT TO THE EMERGENCY DEPARTED, WHERE SHE PASSED OUT AGAIN IN TRIAGE. SHE WAS TREATED WITH IV FLUIDS FOR LOW POTASSIUM, PHOSPHORUS. AND MAGNESIUM. HOSPITAL DISCHARGE RECORDS ATTACHED. DISCHARGE DIAGNOSES INCLUDED: NAUSEA AND VOMITING, SUSPECTED MALNUTRITION, HYPOKALEMIA, HYPOPHOSPHATEMIA. HYPOMAGNESEMIA, PSEUDO HYPOCALCEMIA DUE TO HYPOALBUMINEMIA, SUSPECTED REF CEDING SYNDROME, STARVATION KETOSIS, RESOLVED, DEHYDRATION ON PRESENTATION, SYNCOPE VERSUS PRESYNCOPE EPISODE, LIKELY SECONDARY 10 DEHYDRATION. PATIENT WAS DISCHARGED IN STABLE CONDITION AND WAS ADVISED 10 HAVE HER BALLOON REMOVED. REMAINS SCHEDULED FOR (B)(6) 2022. (B)(6) 2022: PATIENT HAD BALLOON REMOVED ON (B)(6) 2022 AS PLANNED. SHE WAS ASYMPTOMATIC AT THE TIME OF REMOVAL WITHOUT ANY EVIDENCE OF ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1672126 SPATZ3 ADJUSTABLE BALLOON SYSTEM GASTRIC BALLOON LTI TRUE YOU WEIGHT LOSS (ATLANTA) A-SP3US-03K 211221 860005178803

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H