Prescribing Vibrant safely for the appropriate patients
Vibrant should not be used if your patient
- Has a history of complicated/obstructive diverticular disease
- Has a history of intestinal or colonic obstruction, or suspected intestinal obstruction.
- Currently has clinical evidence of significant gastroparesis
- Has a history of significant gastrointestinal disorder, including any form of inflammatory bowel disease or gastrointestinal malignancy (celiac disease is accepted if the subject has been treated and is in remission), and/or anal fissures and fistulas.
- Has a history of Zenker’s diverticulum, dysphagia, esophageal stricture, eosinophilic esophagitis or achalasia
- Is pregnant or lactating
Adverse Events / Side Effects:
Potential adverse events associated with the use of this device may include abdominal pain, abdominal distension, abdominal discomfort, vomiting, nausea, blood in stool, diarrhea, flatulence and proctalgia. In rare cases, obstruction may occur.
Note the safety and effectiveness of the Vibrant System for long-term use in the indicated population, i.e., for more than 8 weeks, has not been evaluated.
- The Vibrant Capsule is MR unsafe. The device has not been evaluated for safety and compatibility in the MR (magnetic resonance) environment. It has not been tested for heating, migration, or image artifact in the MR (magnetic resonance) environment. If patient requires an MRI, verify capsule expulsion via abdominal X-ray before undergoing an MRI examination.
- The capsule should be kept away from implants such as pacemakers, defibrillators, nerve stimulators, and other devices that could be affected by proximity to a DC (direct current) magnetic field.
- Vibrant Capsules must be stored in a safe place, out of the reach of children and/or infants.
- If a child has accidentally swallowed an unused Vibrant capsule, he/she should be brought immediately to a hospital.
- The Vibrant Capsule is magnetic resonance (MR) unsafe. If an MRI is required, verify that no Capsules are currently in your body via abdominal X-ray before undergoing an MRI examination.