Important Safety Information For Patients with a Cardiac Device

Implantable Pacemaker System

Additional Device Information

An implantable pacemaker system relieves symptoms of heart rhythm disturbances. They do this by restoring normal heart rates. A normal heart rate provides your body with the proper amount of blood circulation. The pacemaker system is intended for patients who need rate-adaptive pacing or chronic pacing or for patients who may benefit from synchronizing the pumping of the heart chambers.

Risks associated with pacemaker system implant include, but are not limited to, infection at the surgical site and/or sensitivity to the device material, failure to deliver therapy when it is needed, or receiving extra therapy when it is not needed. After receiving an implantable pacemaker system, you will have limitations with magnetic and electromagnetic radiation, electric or gas-powered appliances, and tools with which you are allowed to be in contact.

This treatment is prescribed by your physician. This treatment is not for everyone. Please talk to your doctor to see if it is right for you. Your physician should discuss all potential benefits and risks with you. Although many patients benefit from the use of this treatment, results may vary.

For further information, please call the Medtronic toll-free number at 1-800-551-5544, x41835 (8:00 a.m. to 5:00 p.m., Monday–Friday, CT) or visit medtronic.com.

Implantable Defibrillator System

Additional Device Information

An implantable cardioverter-defibrillator (ICD) system delivers therapies to treat patients with heart rhythm disorders or who are at significant risk of developing heart rhythm disorders. An ICD is placed inside your body and works automatically.

Risks associated with an ICD system implant include, but are not limited to, infection at the surgical site and/or sensitivity to the device material, failure to deliver therapy when it is needed, or receiving extra therapy when it is not needed. After receiving an ICD system, you will have limitations with magnetic and electromagnetic radiation, electric or gas powered appliances, and tools in which you are allowed to be in contact.

Treatment with an ICD system is prescribed by your physician. This treatment is not for everyone. Please talk to your doctor to see if it is right for you. Your physician should discuss all potential benefits and risks with you. Although many patients benefit from the use of this treatment, results may vary.

For further information, please call the Medtronic toll-free number at 1-800-551-5544, x41835 (8:00 a.m. to 5:00 p.m., Monday–Friday, CT) or visit medtronic.com.

Cardiac Resynchronization Therapy (CRT) Implantable Cardioverter Defibrillator (ICD)

Additional Device Information

A Cardiac Resynchronization Therapy (CRT) Implantable Cardioverter Defibrillator (ICD) system delivers therapies to treat patients who may benefit from synchronizing the pumping of the heart chambers. A CRT ICD also delivers therapies to treat patients with heart rhythm disorders or who are at significant risk of developing heart rhythm disorders. A CRT ICD is placed inside your body and works automatically.

An implantable CRT pacemaker system relieves symptoms of heart rhythm disturbances. It does this by restoring normal heart rates. A normal heart rate provides your body with the proper amount of blood circulation. The pacemaker system is intended for patients who need rate-adaptive pacing or chronic pacing or for patients who may benefit from synchronizing the pumping of the heart chambers.

Risks associated with these implantable device systems include, but are not limited to, infection at the surgical site and/or sensitivity to the device material, failure to deliver therapy when it is needed, or receiving extra therapy when it is not needed. After receiving a CRT pacemaker or CRT ICD system, you will have limitations with magnetic and electromagnetic radiation, electric or gas-powered appliances, and tools with which you are allowed to be in contact.

Treatment with these implantable device systems is prescribed by your physician. This treatment is not for everyone. Please talk to your doctor to see if it is right for you. Your physician should discuss all potential benefits and risks with you. Although many patients benefit from the use of this treatment, results may vary.

For further information, please call the Medtronic toll-free number at 1-800-551-5544, x41835 (8:00 a.m. to 5:00 p.m., Monday–Friday, CT) or visit medtronic.com.

Cardiac Resynchronization Therapy (CRT) Implantable Pacemaker

Additional Device Information

A Cardiac Resynchronization Therapy (CRT) Implantable Pacemaker system delivers therapies to treat patients who may benefit from synchronizing the pumping of the heart chambers.

An implantable CRT pacemaker system relieves symptoms of heart rhythm disturbances. It does this by restoring normal heart rates. A normal heart rate provides your body with the proper amount of blood circulation. The pacemaker system is intended for patients who need rate-adaptive pacing or chronic pacing or for patients who may benefit from synchronizing the pumping of the heart chambers.

Risks associated with these implantable device systems include, but are not limited to, infection at the surgical site and/or sensitivity to the device material, failure to deliver therapy when it is needed, or receiving extra therapy when it is not needed. After receiving a CRT pacemaker system, you will have limitations with magnetic and electromagnetic radiation, electric or gas-powered appliances, and tools with which you are allowed to be in contact.

Treatment with these implantable device systems is prescribed by your physician. This treatment is not for everyone. Please talk to your doctor to see if it is right for you. Your physician should discuss all potential benefits and risks with you. Although many patients benefit from the use of this treatment, results may vary.

For further information, please call the Medtronic toll-free number at 1-800-551-5544, x41835 (8:00 a.m. to 5:00 p.m., Monday–Friday, CT) or visit medtronic.com.

SureScan MRI Pacemaker, ICD, and CRT Patients

An implantable pacemaker, defibrillation, or cardiac resynchronization therapy (CRT) system relieves symptoms of heart rhythm disturbances. It does this by restoring normal heart rates. A normal heart rate provides your body with the proper amount of blood circulation. The pacemaker system is intended for patients who need rate-adaptive pacing or chronic pacing or for patients who may benefit from synchronizing the pumping of the heart chambers. In addition to these functions, an implantable cardioverter-defibrillator (ICD) system delivers therapies to treat patients with heart rhythm disorders or who are at significant risk of developing heart rhythm disorders. A cardiac resynchronization therapy (CRT) pacemaker system (also referred to as CRT-P) or ICD system (also referred to as CRT-D) include the functions of a pacemaker or ICD and also deliver therapies to treat patients who may benefit from synchronizing the pumping of the heart chambers. A CRT-D also delivers therapies to treat patients with heart rhythm disorders or who are at significant risk of developing heart rhythm disorders.

Risks associated with these implantable device systems include, but are not limited to, infection at the surgical site and/or sensitivity to the device material, failure to deliver therapy when it is needed, or receiving extra therapy when it is not needed. After receiving an implantable device system, you will have limitations with magnetic and electromagnetic radiation, electric or gas-powered appliances, and tools with which you are allowed to be in contact.

Your physician may prescribe an MRI scan for you. A magnetic resonance imaging (MRI) scan is a type of medical imaging that uses magnetic fields to create an internal view of the body, which doctors use for diagnostic purposes. Unlike previous generations of heart devices, your SureScan™ heart device system was designed and tested to be used safely with MRI scanners. The electromagnetic fields present during MRI scans have the potential to cause hazardous effects on heart devices, which can result in cardiac tissue heating, inappropriate therapy, and dangerous arrhythmias. Due to the unique design of the SureScan™ heart device systems, these risks are reduced to a very low level so that under specified conditions, patients may safely undergo MRI scans. You can undergo an MRI scan as long as you meet the patient eligibility requirements that Medtronic provides to your heart doctor and the scan is conducted according to Medtronic directions. For example, your heart device system must consist only of a Medtronic SureScan model heart device and the appropriate number of SureScan labeled leads visit mrisurescan.com. Any other combination may result in a hazard to the patient during an MRI scan. The Revo MRI™ and Advisa MRI™ SureScan pacing systems; the Evera MRI™ and Visia AF MRI™ defibrillation systems; the Percepta™, Serena™, and Solara™ CRT-P MRI SureScan systems; and the Claria MRI™, Amplia MRI™, and Compia MRI™ SureScan CRT-D systems are MR Conditional. This means the system is designed to allow patients to undergo MRI when your doctor determines you meet patient eligibility requirements and the scan is conducted according to Medtronic directions.

This treatment is prescribed by your physician. This treatment is not for everyone. Please talk to your doctor to see if it is right for you. Your physician should discuss all potential benefits and risks with you. Although many patients benefit from the use of this treatment, results may vary. For further questions, contact patient services at 1-800-551-5544.

LINQ II™ Insertable Cardiac Monitor System (ICM) and Remote Monitoring

Indications: The LINQ II ICM is an insertable automatically activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:

  • Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
  • Patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia

The device has not been tested specifically for pediatric use.

Contraindications: There are no known contraindications for the insertion of the LINQ II ICM. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated.

Warnings and Precautions: Patients with the LINQ II ICM should avoid sources of diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, therapeutic ultrasound, and radiofrequency ablation to avoid electrical reset of the device, and/or inappropriate sensing as described in the medical procedure and EMI Warnings, Precautions and Guidance Manual. MRI scans should be performed only in a specified MR environment under specified conditions as described in the LINQ II MRI Technical Manual.

Wireless accessories available for use with LINQ II may experience connectivity or performance issues. See product manuals for details and troubleshooting instructions.

Potential Adverse Events or Potential Complications: Potential adverse events from the LINQ II ICM include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin.

There are no known adverse events associated with the use of any LINQ II ICM wireless accessory.

See the device manuals for detailed information regarding the implant procedure, indications/intended use, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 (Technical Services), 1-800-551-5544 (Patient Services), and/or consult the Medtronic website at medtronic.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.