Medical and dental procedures

Peace of mind for your procedures

Some medical and dental procedures may damage or affect your subcutaneous or transvenous implantable defibrillator (S-ICD or TV-ICD). Learn about these procedures below and be sure to tell your dentist and physicians that you have an implanted device so they may take necessary precautions.

Doctor speaking with a patient in the doctor’s office

Procedures that may affect your device

The following medical and dental procedures can affect your implanted device and/or injure you. If you must have any of these procedures, be sure to talk with your heart specialist and the health care provider performing the procedure about what can be done to protect you and your device.

Magnetic Resonance Imaging (MRI)

An MRI is a diagnostic test that uses a powerful magnet and radio waves to produce images of the human body. You may be able to have an ImageReady™ MR-Conditional TV-ICD or S-ICD System. Talk to your health care provider about the capabilities of your particular device and leads.

TV-ICD MRI Information and Safety

S-ICD MRI Information and Safety

If your system is not eligible to be scanned or if the required conditions are not met, an MRI scan can severely damage your implanted device or injure you and should not be performed. Your health care provider must always confirm that both you and your implanted device are eligible and ready for an MRI in order to undergo this procedure.

Hospitals keep MRI equipment in rooms marked with signs that indicate magnets are inside. Do not go inside these rooms unless your physician has confirmed that you meet the requirements for an MRI scan.

Talk to your doctor before having these procedures

Diathermy

Diathermy should not be performed as it uses an electrical field to apply heat to tissues in the body and could damage your device or injure you.

Electrocautery

Electrocautery is used during surgical procedures to stop vessels from bleeding. Speak to your health care provider before undergoing this procedure.

Electrolysis and Thermolysis

These dermatology or hair removal procedures pass electrical currents into the skin. Talk with your health care provider before having either of these treatments.

External defibrillation

Typically used in medical emergencies, this procedure uses external equipment to deliver an electrical shock to your heart to restore a rapid and irregular heart rate to a normal rhythm. External defibrillation can affect your S-ICD or TV-ICD device, but can still be performed if necessary. Be sure to contact your health care provider as soon as possible if you receive external defibrillation to verify that your device is functioning properly.

Lithotripsy

Used to break up stones in the urinary tract, such as kidney stones, lithotripsy can damage your S-ICD or TV-ICD device if certain precautions are not taken.

Therapeutic radiation treatment for cancer

This procedure for cancer can affect your device and will require special precautions. If you need radiation treatment, talk with your heart doctor and the doctor performing the procedure.

Transcutaneous Electrical Nerve Stimulation (TENS) Unit

This device prescribed by doctors or chiropractors to control chronic pain can adversely affect your device.

Talk to your heart care team before using a TENS unit. Make sure your doctor or chiropractor knows you have an implanted device.

Procedures that will not affect your S-ICD or TV-ICD

Most medical and dental procedures will not affect your ICD device. Some examples include:

Dental drills and cleaning equipment
Diagnostic X-rays
Diagnostic ultrasound procedures
Mammograms

Note: Mammograms will not interfere with your device. However, your device could be damaged if it gets compressed in the mammogram machine. Make sure the doctor or technician knows you have an implanted device.

EKG machines
CT scans

Talk to your doctor

If you need medical or dental treatment, tell your dentist or doctor you have an S-ICD or TV-ICD device and show them your Medical Device ID Card. Your health care team can contact your heart specialist and work together to find a treatment that works best for you and your device.

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Implantable Cardioverter Defibrillators - Important Safety Information

An implantable cardioverter defibrillator is designed to monitor and treat heart rhythm problems, greatly reducing the risks associated with them. These devices are sensitive to strong electromagnetic interference (EMI) and can be affected by certain sources of electric or magnetic fields. With all medical procedures there are risks associated. In regard to an implanted ICD, the risks include but are not limited to inappropriate shock, lead moves out of place, loss of stimulation capability, allergic reaction, fluid underneath the skin, and infection. In rare cases device failure or death can occur. Be sure to talk with your doctor so that you thoroughly understand all of the risks and benefits associated with the implantation of this system. To obtain a copy of the device Patient Handbook for more detailed device safety information, go to www.bostonscientific.com, or you can request a copy by calling 1-866-484-3268 or writing to Boston Scientific, 4100 Hamline Ave. N., St. Paul, MN 55112.

S-ICD™ System - Important Safety Information

An implantable cardioverter defibrillator is designed to monitor and treat heart rhythm problems, greatly reducing the risks associated with them. There are risks associated with this device including, but not limited to, allergic reactions, bleeding, death, fever, infection, kidney failure, need for surgical replacement, nerve damage, stroke and tissue damage. Electrical or magnetic fields can affect the device. In some cases, the device may not respond to irregular heartbeats or may deliver inappropriate shocks and in rare cases severe complications or device failures can occur. Your physician should discuss all potential benefits and risks with you and describe the appropriate medical care.

Refer to the product labeling for specific indications, contraindications, warnings/precautions and adverse events. Rx only.

Device Quality and Reliability

It is Boston Scientific’s intent to provide implantable devices of high quality and reliability. However, these devices may exhibit malfunctions that may result in lost or compromised ability to deliver therapy. Refer to Boston Scientific’s CRM product performance report on www.bostonscientific.com for more information about device performance, including the types and rates of malfunctions that these devices have experienced historically. While historical data may not be predictive of future device performance, such data can provide important context for understanding the overall reliability of these types of products. Also, it is important that you talk with your doctor about the risks and benefits associated with the implantation of a device.

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