Patient Safety Information
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.
92481216 (Rev. A)
LATITUDE™ (NXT) Patient Management System
Important Safety Information
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 92481216 (Rev. A)