IMPORTANT SAFETY INFORMATION REFLUX TESTING AND TREATMENT

BARRX™ RADIOFREQUENCY ABLATION SYSTEM

Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. Rx only.

Risk Information: The following are transient side effects that may be expected after treatment: chest pain, difficulty swallowing, painful swallowing, throat pain, and/or fever. Potential complications include mucosal laceration, minor or major bleeding, endoscopic clipping to manage mucosal laceration or bleeding, perforation of the stomach, esophagus, or pharynx, surgery to manage perforation, esophageal stricture, endoscopic dilation to manage stricture, pleural effusion, transfusion secondary to major bleeding, cardiac arrhythmia, aspiration, infection and death.

BRAVO™ REFLUX TESTING SYSTEM

Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. Rx only.

Risk Information: The risks of the Bravo™ reflux testing system include premature detachment, discomfort or pain, failure to detach, failure to attach, capsule aspiration, capsule retention, tears in the mucosa, bleeding, and perforation. Endoscopic placement or nasal intubation may present additional risks. Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur. Because the capsule contains a small magnet, patients should not have an MRI study within 30 days of undergoing the Bravo™ reflux test. Please refer to the product user manual or medtronic.com/GI for detailed information.

Digitrapper ™ PH AND IMPEDANCE TESTING SYSTEM

Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. Rx only.

Risk Information: The risks of catheter insertion into the nasal passage associated with the Digitrapper™ pH and impedance testing system include: discomfort, nasal pain, minor bleeding, runny nose, throat discomfort, irregular heartbeat with dizziness, and perforation. In rare instances, the catheter may be misdirected into the trachea causing coughing or choking, or the catheter may shift up or down causing false results. Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur. The system is not compatible for use in an MRI magnetic field. Please refer to the product user manual or medtronic.com/GI for detailed information. 

EndoFlip™ IMPEDANCE PLANIMETRY SYSTEM

Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. Rx only.

Risk Information: The risks of the EndoFlip™ impedance planimetry system are, but are not limited to: allergic reaction, anaphylaxis, bleeding, cardio-respiratory complications, dental trauma, infection, pain, perforation, pulmonary aspiration, and vasovagal response. Please refer to the product user manual or medtronic.com/GI for detailed information.

ManoScan™ ESO HIGH RESOLUTION MANOMETRY SYSTEM

Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. Rx only.

Risk Information: The risks of catheter insertion into the nasal passage associated with the ManoScan™ ESO high resolution manometry system include: discomfort, nasal pain, minor bleeding, runny nose, throat discomfort, irregular heartbeat with dizziness, and perforation. In rare instances, the catheter may be misdirected into the trachea causing coughing or choking, or the catheter may shift up or down causing false results. Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur. These systems are not compatible for use in an MRI magnetic field. Please refer to the product user manual or medtronic.com/GI for detailed information.

Information and resources on this site should not be used as a substitute for medical advice from your doctor. Always discuss diagnosis and treatment information including risks with your doctor. Keep in mind that all treatment and outcome results are specific to the individual patient. Results may vary.