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Important Safety Information

Cardiac Resynchronization Therapy Devices

Cardiac resynchronization therapy pacemakers (CRT-P) and defibrillators (CRT-D) are designed to treat heart failure patients who 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. CRT-P and CRT-D systems are not for everyone, including people with separate implantable cardioverter-defibrillators (CRT-P only) or certain steroid allergies. Procedure risks include infection, tissue damage, and kidney failure. Patients who should not receive this device include: patients who have additional medical conditions that may not allow the pacemaker to function appropriately (CRT-P only) and patients whose ventricular rhythm disturbances or heart failure have a reversible or temporary cause. In some cases, the device may be unable to detect or appropriately respond to your heart rhythm (CRT-P and CRT-D) or may deliver inappropriate shocks (CRT-D only). In rare cases severe complications or device failures can occur. Electrical or magnetic fields can affect the device. Only your doctor knows what is right for you. These devices are available by prescription only. Individual results may vary. For further safety information see the Physicians Instructions for Use page on www.bostonscientific.com/ifu or call 1-866-484-3268.

(Rev. D)

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Implantable Cardioverter Defibrillators from Boston Scientific CRM

An implantable cardioverter defibrillator is designed to monitor and treat heart rhythm problems, greatly reducing the risks associated with them. But it is not for everyone, including people with certain steroid allergies. Procedure risks include infection, tissue damage, and kidney failure. Patients who should not receive this device include: patients whose ventricular rhythm disturbances have a reversible or temporary cause and patients with certain types of atrial rhythm disturbances. Procedure risks include infection and tissue damage. In some cases, the device may not respond to irregular heartbeats or may deliver inappropriate shocks. In rare cases severe complications or device failures can occur. Electrical or magnetic fields can affect the device. Only your doctor knows what is right for you. This device is available by prescription only. Individual results may vary. For further safety information see the Physicians Instructions for Use page on www.bostonscientific.com/ifu or call 1-866-484-3268.

(Rev. D)

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Pacemakers from Boston Scientific CRM

A pacemaker system is designed to monitor and treat your heart rhythm problems, greatly reducing the risks associated with them. But it is not for everyone, including patients with certain steroid allergies. Procedure risks include infection, tissue damage, and kidney failure. Patients who have additional medical conditions that may not allow the pacemaker to function appropriately should not receive a device. In rare cases severe complications or device failures can occur. Electrical or magnetic fields can affect the device. Only your doctor knows what is right for you. This device is available by prescription only. Individual results may vary. For further safety information see the Physicians Instructions for Use page on www.bostonscientific.com/ifu or call 1-866-484-3268.

(Rev. D)

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LATITUDE® Patient Management System from Boston Scientific CRM

The LATITUDE Patient Management system is used to remotely communicate with a compatible pulse generator device from BSC CRM and send data to a central database. The LATITUDE system is contraindicated for use with any pulse generator other than a device from BSC CRM.

The LATITUDE system is designed to tell your doctor within 24 hours if alert conditions are detected by the Communicator. Alert notifications are based on clinician configured alert settings. However, alert notification cannot occur if:

•  The Communicator is unplugged or is not able to connect to the LATITUDE system through an active phone line.

•  Your device and the Communicator cannot establish and complete a communication session. This session must be initiated by you if you have a device that uses inductive telemetry (Communicator that has a wand).

•  The Communicator becomes damaged or it malfunctions.

•  The patient is not compliant with prescribed use or is not using the LATITUDE system as described in the patient manual.

Up to two weeks may go by before the LATITUDE system detects the events mentioned above, and additional time may be required for notification and resolution of the condition.

The wanded and wireless Communicator uses a radio frequency (RF) communication system to communicate with an optional weight scale and blood pressure monitor. This communication can be disrupted by electromagnetic interference. Avoid placing your Communicator next to or in the immediate vicinity of other wireless products and sources of electromagnetic energy. The wireless Communicator uses RF to also send and receive signals from the implanted device (RF enabled devices only). Using the blue Interrogate button more than as prompted by your Communicator or as instructed by your physician may lead to a decrease in the battery life of your implanted device. Your communicator is designed to be used in the continental US, Alaska, Hawaii, and Puerto Rico. These devices are available by prescription only.

(Rev. J)

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