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Patient Safety Information

Cardiac Resynchronization Therapy Devices

Cardiac resynchronization therapy pacemakers (CRT-P) and defibrillators (CRT-D) are designed to treat heart failure patients who may or may not have symptoms or who may have symptoms despite the best available drug therapy. They are also designed to help your heart pump more effectively and meet your body’s need for blood flow. 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.

(Rev. K) 

Implantable Cardioverter Defibrillators

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.

(Rev. K)

Pacemakers

A pacemaker system is designed to monitor and treat your 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 an implanted pacemaker, the risks include but are not limited to inappropriate heart rate response to exercise, 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.

(Rev. K)

S-ICD™ System

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.

(Rev. K)

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.

(Rev. K)

LATITUDE™ (NXT) Patient Management System

LATITUDE™ NXT Patient Management is a remote monitoring system that gives your health care provider access to your implanted device data. The LATITUDE Patient Management system is not intended to assist with medical emergencies. If you are not feeling well, call your physician or 911. The Communicator does not provide continuous monitoring.

The Communicator is designed to operate on standard telephone lines like those found in most homes. The Communicator may work on other telephone systems, such as Digital Subscriber Line (DSL) and Voice Over IP (VoIP) Internet systems, if those systems provide an analog interface for connecting the Communicator.

The Communicator is designed to work only with the implanted device of the patient for whom it was prescribed. It will not work with other patients’ implanted devices and should be used only as authorized by the prescribing physician. The Communicator is not for use with any pulse generator other than a Boston Scientific device. Ask your physician if you have questions about any risks with using the Communicator or your implanted device.

It is very important that the Communicator remain plugged into the power outlet. Your communicator should remain connected to a telephone line, ethernet adaptor or cellular adaptor. Some household appliances and other sources of electromagnetic energy could interfere with the communication between your Communicator and your implanted device. You should be at least 36 inches (3 ft.) away from televisions, VCRs, DVD players, personal computers, and other electronic equipment, when you are using the Communicator.

It is recommended that the customer install a surge arrestor in the electrical outlet to which the Communicator is connected.

Rx only (Rev.D)

LATITUDE™ Patient Management System

LATITUDE™ Patient Management is a remote monitoring system that provides implanted device data to both clinicians and cardiac device patients. The LATITUDE Patient Management system is not intended to assist with medical emergencies. If you are not feeling well, call your physician or 911. The Communicator is designed to work only with the implanted device of the patient for whom it was prescribed. It will not work with other patients’ implanted devices and should be used only as authorized by the prescribing physician. The Communicator is contraindicated for use with any pulse generator other than a Boston Scientific device. Ask your physician if you have questions about any risks with using the Communicator or your implanted device.

It is very important that the Communicator remain plugged into the power outlet and telephone line. It is recommended that the customer install a surge arrestor in the electrical outlet to which the Communicator is connected. The Communicator is designed to operate on standard, analog telephone lines like those found in most homes. The Communicator may work on other telephone systems, such as Digital Subscriber Line (DSL) and Voice Over IP (VoIP) Internet systems, if those systems provide an analog interface for connecting the Communicator. The Communicator should not be connected to a digital phone interface, such as those commonly used in some businesses, hotels, and managed care facilities where telephones are typically provided by the facility. Your Communicator is designed to be used in the continental United States, Alaska, Hawaii, and Puerto Rico. The Communicator may not communicate with your implanted device if you are too close to some household appliances. You should be at least 36 inches (3 ft.) away from televisions, VCRs, and personal computers when you are using the Communicator. Avoid placing your Communicator next to or in the immediate vicinity of other wireless products and sources of electromagnetic energy.

Rx only (Rev.Q)

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