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 800-551-5544, (7:00 a.m. to 6:00 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 800-551-5544, (7:00 a.m. to 6:00 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 800-551-5544, (7:00 a.m. to 6:00 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 800-551-5544, (7:00 a.m. to 6:00 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; Cobalt™ and Crome™ ICD 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 800-551-5544.
LINQ family of insertable cardiac monitors (ICMs) systems and accessories
The Reveal LINQ™ 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.
This device has not been tested specifically for pediatric use.
The LINQ II™ ICM is an insertable automatically-activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in adult patients, and in pediatric patients who are at least 2 years old, 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
Possible risks associated with the implant of a LINQ Family ICM (LINQ II ICM or Reveal LINQ ICM) include, but are not limited to, infection at the surgical site, device migration, erosion of the device through the skin and/or sensitivity to the device material. Accessories available for use with LINQ Family ICMs may experience connectivity or performance issues. See product manuals for details and troubleshooting instructions.
LINQ Family ICMs are prescribed by your physician and are 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 product, results may vary.
For further information, please call the Medtronic toll-free number at 800-551-5544 (7:00 a.m. to 7:00 p.m., Monday–Friday, Central Time) or see the Medtronic website at medtronic.com.