BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBERA INTRAGASTRIC BALLOON SYSTEM

    MDR report key: 6057588 · Received October 26, 2016

    Report

    Report Number
    3006722112-2016-00309
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    July 15, 2016
    Report Date
    September 28, 2016
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    UDI-DI
    10811955020619
    PMA / PMN Number
    P140008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO THE FDA ON 10/26/2016. THE EXPLANTING PHYSICIAN WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY APOLLO. DEVICE LABELING ADDRESSES THE EVENT AS FOLLOWS: PRECAUTIONS: ANTIEMETICS, ANTISPASMODIC, AND ANTICHOLINERGIC DRUGS MAY BE PRESCRIBED TO LESSEN THE EARLY PLACEMENT SYMPTOMS SUCH AS NAUSEA, VOMITING, AND ABDOMINAL PAIN. PATIENTS WILL NEED TO IMMEDIATELY CONTACT THEIR PHYSICIAN FOR ANY SEVERE OR UNUSUAL SYMPTOMS. PLACEMENT OF THE BALLOON WITHIN THE STOMACH PRODUCES AN EXPECTED AND PREDICTABLE REACTION CHARACTERIZED MOST COMMONLY BY A FEELING OF HEAVINESS IN THE ABDOMEN, NAUSEA AND VOMITING, GASTROESOPHAGEAL REFLUX, BELCHING, ESOPHAGITIS, HEARTBURN, DIARRHEA AND, AT TIMES, ABDOMINAL, BACK OR EPIGASTRIC PAIN AND CRAMPING. FOOD DIGESTION MAY BE SLOWED DURING THIS ADJUSTMENT PERIOD. THESE SYMPTOMS CAN BE TREATED WITH ANTIEMETIC, ANTISPASMODIC, AND ANTICHOLINERGIC MEDICATIONS. TYPICALLY THE STOMACH ACCLIMATES TO THE PRESENCE OF THE DEVICE WITHIN THE FIRST 2 WEEKS. IN ORDER TO PREVENT OR AMELIORATE THE SYMPTOMS MOST FREQUENTLY EXPERIENCED DURING THE ADJUSTMENT PERIOD, IT IS RECOMMENDED THAT THE PHYSICIAN USE PROTON PUMP INHIBITORS (PPIS), ANTIEMETICS, ANTISPASMODICS, AND ANTICHOLINERGIC MEDICATIONS PROPHYLACTICALLY (BEFORE ORBERA PLACEMENT). PATIENTS SHOULD BE ADVISED TO IMMEDIATELY CONTACT THEIR PHYSICIAN FOR ANY UNUSUALLY SEVERE OR WORSENING SYMPTOMS. THE PHYSIOLOGICAL RESPONSE OF THE PATIENT TO THE PRESENCE OF ORBERA MAY VARY DEPENDING UPON THE PATIENT'S GENERAL CONDITION AND THE LEVEL AND TYPE OF ACTIVITY. THE TYPES AND FREQUENCY OF ADMINISTRATION OF DRUGS OR DIET SUPPLEMENTS AND THE OVERALL DIET OF THE PATIENT MAY ALSO AFFECT THE RESPONSE. EACH PATIENT MUST BE MONITORED CLOSELY DURING THE ENTIRE TERM OF TREATMENT IN ORDER TO DETECT THE DEVELOPMENT OF POSSIBLE COMPLICATIONS. EACH PATIENT SHOULD BE INSTRUCTED REGARDING SYMPTOMS OF DEFLATION, GASTROINTESTINAL OBSTRUCTION, ULCERATION AND OTHER COMPLICATIONS WHICH MIGHT OCCUR, AND SHOULD BE ADVISED TO CONTACT HIS/HER PHYSICIAN IMMEDIATELY UPON THE ONSET OF SUCH SYMPTOMS.

    Description of Event or Problem · 1

    REPORTED AS: A PATIENT WITH THE ORBERA INTRAGASTRIC BALLOON HAD "FAINTED TWICE, BP IS 84/50 HAVING DIFFICULTY EATING." THE DEVICE WAS REMOVED IN LONDON AND AT THE TIME OF REMOVAL 700CC OF FLUID WAS REMOVED WHEN ONLY 500 CC WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707589 ORBERA INTRAGASTRIC BALLOON SYSTEM INTRAGASTRIC BALLOON LTI APOLLO ENDOSURGERY, INC. B-4800 RWAP0000 10811955020619

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention STEROIDS| ZYERTEC