Important safety information

The Medtronic Symplicity™ blood pressure procedure, just like any medical procedure, has risks. However, clinical studies show that these risks and side effects are rare.

The safety and effectiveness of the Symplicity™ blood pressure procedure have not been evaluated in patients who are pregnant, nursing, or who are younger than 18 years old.

Careful consideration should be given to use of the Symplicity™ blood pressure procedure in patients with aortic grafts or who have received a renal stent in the last three months.

Implantable pacemakers and implantable cardioverter/defibrillators (ICDs) may be adversely affected by RF ablation. If you have a pacemaker or ICD, your doctor will follow up with steps to take before receiving the Symplicity™ blood pressure procedure.

You should not receive the blood pressure procedure if:

• You have an allergy or suspected allergy to nitinol
• You cannot tolerate atropine, nitroglycerine, or systemic anticoagulation medication
• A reduction in your blood pressure would be considered hazardous to your health
• Your doctor determines that your arteries are too narrow or too wide for the catheter

Since you may experience pain when radiofrequency energy is delivered, your doctor will deliver pain medication at least five minutes prior to the procedure.

Your heart rate may drop during the ablation procedure. If this happens, your doctor will administer medication to bring your heart rate back up.

Intervention risks: death, cardiopulmonary arrest, heart rhythm disturbances, including bradycardia, formation of blood clots and/or embolism (which may result in ischemic events such as myocardial infarction, pulmonary embolism, stroke, kidney damage, or peripheral ischemia), retroperitoneal hematoma, hematoma, bruising, bleeding, arterial damage, arterial spasm, arterial stenosis, arterial dissection or perforation, renal artery aneurysm, kidney perforation, pseudoaneurysm, AV fistula, pain, skin burns, and thermal injury to the vasculature or other structures from energy application.

Contrast agents, narcotics, anxiolytics, other pain medications and anti-vasospasm agents are also commonly used during the procedure or after the procedure; use of these agents is associated with known risks.

Other treatment risks include: proteinuria, hematuria, electrolyte disturbances, worsening renal function, hypotension, hypertension, orthostatic hypotension, hypotension causing end organ hypoperfusion, nausea, and vomiting.

Biological hazards: risks of infection, toxicity, abnormal hematology profile, allergy, hemorrhage, and pyrogenicity.

Environmental hazards: consistent with standard hospital protocols for proper use and disposal of biological wastes.

Radiation hazards: consistent with normal use of X-ray during interventional procedures.
 

Information contained herein is not medical advice and should not be used as an alternative to speaking with your doctor. Discuss indications, contraindications, warnings, precautions, adverse events and any further information with your health care professional.

For further information, contact your local Medtronic representative and/or consult the Medtronic website at cema.medtronic.com.