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.

We’re here to help

Our patient services team is here to support you throughout your journey.

(866) 484-3268

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. Some of the risks encountered during the implant procedure include, but are not limited to, the following: Bleeding, formation of a blood clot, damage to adjacent structures (tendons, muscles, nerves), puncture of a lung or vein, damage to the heart (perforation or tissue damage), dangerous arrhythmias, heart attack, stroke, death. Some of the risks encountered after the ICD system is implanted may include, but are not limited to, the following: Infection, erosion of the skin near your device, lead(s) may move out of place in the heart, device may move from the original implant site, difficulty coping with having an implanted device. The device might be prevented from shocking or pacing due to electromagnetic interference. Electrodes on the lead or the pacing pulses may cause an irritation or damaging effect on the surrounding tissues, including heart tissue and nerves. You may receive a shock or pacing therapy when it is not needed (unnecessary therapy). The device might not be able to detect or appropriately treat your heart rhythms. The device may exhibit malfunctions that may result in lost or compromised ability to deliver therapy. You may experience some discomfort from the incision as you recover from the surgery. With all medical procedures there are risks associated. 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. Rx only

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. These devices are sensitive to strong electromagnetic interference (EMI) and can be affected by certain sources of electric or magnetic fields. As with all ICD systems, there are risks associated with the S-ICD System. Some of the risks that may be encountered during the implant procedure include the following: Formation of a blood clot; damage to adjacent structures (tendons, muscles, nerves); injury to or pain in upper extremity including clavicle, shoulder, and arm; dangerous arrhythmias; stroke. After the system is implanted, other infrequent risks may occur, including: Infection; erosion of the skin near your device; electrode and device may move out of place; fainting (syncope); delivery of a shock or therapy when it is not needed (unnecessary therapy); inability to detect or appropriately treat your heart rhythms due to electromagnetic interference or malfunction; difficulty coping with having an implanted device; bleeding or formation of a blood clot (hematoma); pain and discomfort; injury to or pain in upper extremity including clavicle, shoulder, and arm; allergic reaction; need for surgical replacement. You may experience some discomfort from the incision as you recover from the surgery. In rare cases severe complications can occur, such as device failures or death. 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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