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Important Safety Information

Cardiac Resynchronization Therapy Devices from Boston Scientific CRM

Cardiac resynchronization therapy pacemakers (CRT-P) and defibrillators (CRT-D) are used to treat heart failure patients who have symptoms despite the best available drug therapy. These patients also have an electrical condition in which the lower chambers of the heart contract in an uncoordinated way and a mechanical condition in which the heart pumps less blood than normal. CRT-Ps and CRT-Ds 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. In some cases, the device may be unable to respond to your heart rhythm (CRT-P only) or may be unable to respond to irregular heartbeats 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.

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Implantable Cardioverter Defibrillators from Boston Scientific CRM

An implantable cardioverter defibrillator can protect you from the effects of sudden cardiac arrest by reviving your heart rhythm. But it is not for everyone, including people with certain steroid allergies. 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 cardiologist knows what is right for you. This device is available by prescription only. Individual results may vary.

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Pacemakers from Boston Scientific CRM

A pacemaker system can monitor and treat your heart rhythm by delivering electrical energy to pace your heart when it senses a slow rhythm. But it is not for everyone, including patients with certain steroid allergies. Patients who have additional medical conditions that may not allow the pacemaker to function appropriately should not receive a device. Procedure risks include infection, tissue damage and kidney failure. In some cases, the device may not respond to your heart rhythm. 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.

(Rev. C)

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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. 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).

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.

Additionally, use the blue Interrogate button only as instructed by your physician. Excessive use can lead to a decrease in the battery life of your implanted device. The wanded and wireless Communicator uses a radio frequency (RF) communication system to send and receive signals from the optional weight scale and blood pressure monitor. The wireless Communicator uses RF to also send and receive signals from the implanted device (RF enabled devices only). Communication can be disrupted by other wireless products and sources of electromagnetic energy. Your communicator is designed to be used in the continental US, Alaska and Hawaii. These devices are available by prescription only.

(Rev. H)

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