The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.Device labeling addresses the reported events 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.Patients need to be evaluated and the device removed at or within 6 months of placement.Clinical data does not exist to support use of an individual orbera beyond 6 months.Adverse events: it is important to discuss all possible complications and adverse events with your patient.Complications that may result from the use of this product include the risks associated with the medications and methods utilized in the endoscopic procedure, the risks associated with any endoscopic procedure, the risks associated with the orbera intragastric balloon specifically, and the risks associated with the patient's degree of intolerance to a foreign object placed in the stomach.Possible complications: abdominal or back pain, either steady or cyclic.Injury to the lining of the digestive tract as a result of direct contact with the balloon, grasping forceps, or as a result of increased acid production by the stomach.This could lead to ulcer formation with pain, bleeding or even perforation.Surgery could be necessary to correct this condition.Gastric discomfort, feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon.Continuing nausea and vomiting.This could result from direct irritation of the lining of the stomach or as a result of the balloon blocking the outlet of the stomach.It is even theoretically possible that the balloon could prevent vomiting (not nausea or retching) by blocking the inlet to the stomach from the esophagus.Potential risks associated with upper endoscopic procedures include, but are not limited to: abdominal cramping and discomfort from the air used to distend the stomach, sore or irritated throat, bleeding, infection, tearing of the esophagus or stomach, and aspiration pneumonia.The risk increases if additional procedures are performed the event of necrosis was reported in the us pivotal clinical study and was experienced by three of the participants.The event of tachycardia was reported in the us pivotal clinical study and was experienced by one of the participant.
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Reported as: a patient with orbera intragastric balloon had "complained of some discomfort, bloating, and hiccups two days after implant.Later the patient was found to be hyperventilating and was directed to go to the nearest emergency room (er).The patient had blood workup at the er; the glucose level was elevated.The patient was found to be tachycardic.A computerized tomography (ct) scan was performed which showed the abdomen enlarged (acute gastric dilation) filled with fluid and air in the stomach wall.The er physician confirmed the patient experiencing gastric dilation, and to be obstructed and vomiting.The balloon looked like it was blocking the outlet.A nasogastric tube (ng) was placed in the patient and 3.4 liters of brown fluid was drained.The device was removed the next day.The patient had mucosal necrosis, bleeding and ulceration.Upon device removal, the er physician observed 80% of the stomach mucosa was black and dead.The antrum was not necrotic.Physician also noted a perfectly round spot, an imprint in the stomach, possibly made by pressure from the balloon.The cause or etiology is unknown.The patient was monitored in the icu.The fundus of the patient's stomach had necrosis and a gastrectomy was performed.The patient was discharged home and is currently doing well.".
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