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 with Barrx™ radiofrequency ablation system: chest pain, difficulty swallowing, painful swallowing, throat pain and/or fever. Potential complications include: mucosal laceration, minor and major acute bleeding, stricture, perforation, cardiac arrhythmia, pleural effusion, aspiration, and infection. Potential complications that have not been observed include: death. Please refer to the product user manual or medtronic.com/GI for detailed information. 


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, failure to detach, failure to attach, capsule aspiration, capsule retention, tears in the mucosa, bleeding, and perforation. Endoscopic placement 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: dental trauma, minor or major bleeding, mucosal injury, mucosal laceration or perforation, inflammation, infection, fever, pain, aspiration, cardiac dysrhythmia, pleural effusion, vasovagal response and death. Those associated with endoscopy include, but are not limited to: perforation, hemorrhage, aspiration, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest, infection / fever, bacteremia, allergic reaction to medication, anaphylactic reactions to topical anesthesia, damage to blood vessels, nerve damage and death. 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.