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THIS DEVICE IS COMMERCIALLY AVAILABLE FOR USE IN SELECT INTERNATIONAL MARKETS. 
OVERVIEW
HOW IT WORKS
FAQS
FLEXIBILITY AND EFFECTIVENESS TO FIT HOW YOU LIVE
  • MRI compatible
  • Smooth, curved shape
  • Enhanced battery longevity
  • Daily wireless monitoring between office visits

 

The Assurity MRI™ pacemaker combines advanced features with a small size. The powerful, lightweight device allows a smaller incision and requires a smaller pocket for implantation.1,2

Equipped with the ability to connect wirelessly to Merlin.net™ Patient Care Network, the Assurity MRI pacemaker regularly communicates important information about your device to your hospital or clinic for your doctor to review. This means you may need to visit your doctor less often.

With the Assurity MRI pacemaker, you can receive magnetic resonance imaging (MRI) scans under certain parameters.

BENEFITS

*Actual battery life depends on how frequently your device sends electrical signals to your heart, and whether it is a single- or dual-chamber device.

RISKS
  • A small number of patients develop complications from the operation to implant the pacemaker and the leads in the body. These can include the following complications, which can usually be corrected or cured:
    • Infection
    • A reaction to a drug used during surgery
    • Blood loss
    • Damage to a blood vessel, the heart wall or other organ
  • After the surgery, you may feel some discomfort or feel tired, but these feelings only last a short time. Some patients, however, may continue to feel a bit uncomfortable in the area where the pacemaker was implanted.
  • Modern pacemakers have many safety features. Sometimes a pacemaker may not act properly because it is being affected by outside sources of electromagnetic energy.
  • It is also possible for the tip of the lead to shift in the heart so that the pulse is no longer effective.
  • Very rarely, the device may slip out of the “pocket” in the chest.
  • Finally, remember these are man-made devices. It is important to monitor the device regularly with follow-up visits as often as your doctor recommends.
  • Contact your doctor if:
    • You notice you are tired, short of breath or your heart rate is changing
    • You notice the wound is red, hot, swollen, more painful or beginning to drain fluid
    • Symptoms you had before the pacemaker was implanted seem to return
    • Daily wireless monitoring between office visits

 

DEVICE SPECIFICATIONS

SINGLE CHAMBER

Dimensions (mm)
47 x 50 x 6
Weight (g)
20

DUAL CHAMBER

Dimensions (mm)
47 x 50 x 6
Weight (g)
20

 

HOW THE ASSURITY MRI™ PACEMAKER WORKS

The Assurity MRI™ pacemaker is made up of two components: a pulse generator and leads. The pulse generator contains the battery and electronic circuitry that send electrical pulses to the heart. This stimulates the heart and causes it to beat at a normal rhythm. The electrical pulses are very small.

The leads are thin wires that are inserted through a vein and connect the pulse generator to the heart. The leads pick up your own heart rhythm and transmit this information to the pulse generator, which adapts its response to your needs.

The programmer is an external tabletop computer that your doctor uses to change the pacemaker settings and download data stored in the pacemaker. Your doctor can adjust the therapy based on your needs over time without the need for further surgery.

The Assurity MRI pacemaker is an MR conditional device, which means that your doctor can set it so that you can get a magnetic resonance imaging (MRI) scan under certain parameters.

  • CAN I GET AN MRI SCAN WITH THIS PACEMAKER?

    The Assurity MRI™ pacemaker is an MR conditional (also referred to as MRI ready) pacemaker. You can receive an MRI scan with the Assurity MRI pacemaker under certain parameters; talk with your doctor prior to having any MRI scan. Prior to have any MRI scan, talk with your doctor about the MRI scan you need and any specific parameters.

    If you have an Abbott MR conditional pacemaker, download your MRI patient ID card.

  • WHY IS BEING MRI READY IMPORTANT?
    MRI is fast becoming a preferred diagnostic imaging tool used by physicians in the treatment of cancer, stroke, heart-related conditions, and musculoskeletal disorders or injury. Because of its high-resolution image quality and low radiation risk, MRI is often selected over other diagnostic techniques. The use of MRI continues to grow. By having an MR conditional pacemaker, you will have the option of getting an MRI scan if the need arises.
  • HOW DO I KNOW IF I CAN SAFELY UNDERGO AN MRI SCAN WITH MY PACEMAKER?
    As a patient with an MR conditional system, you should have received a special patient card that identifies you as having an MR conditional system. It is important for you to carry this card with you at all times. Sometimes MRI procedures are planned, and other times they are needed under unexpected circumstances. You will need to let the healthcare professionals caring for you, as well as the MRI technologist or radiologist, know that you have an MR conditional system. With an MR conditional system, you can be comfortable knowing that the device has been designed for safety under set conditions in the MRI environment.
  • WHAT CAN I EXPECT BEFORE, DURING AND AFTER AN MRI SCAN WITH MY PACEMAKER?

    Your pacemaker needs to be put into special MRI settings for you to safely undergo an MRI scan. There are two ways your doctor might do this. The first way is for your doctor to program your pacemaker to the special MRI settings ahead of time and store those settings in the pacemaker. This programming happens during a follow-up appointment. Then, when you need an MRI scan, the MRI settings are enabled by a clinician, who places a small hand-held device over your pacemaker. The hand-held device uses radio waves to communicate with your pacemaker and enable the preprogrammed MRI settings. Activating the MRI settings is painless and takes only moments. The second method involves programming your device to MRI settings when it is determined you need an MRI scan. With this method, your doctor uses the programmer to temporarily set your device to MRI settings before your MRI scan. You can then safely undergo the MRI procedure.

    After the MRI scan, your device needs to be returned to its regular settings. In other words, your MRI settings need to be disabled. This can be accomplished in the same two ways in which your MRI settings were enabled. With the first method, the hand-held device is placed back over your device to disable MRI settings and enable your pacemaker to go back to its permanent settings. With the second method, the programmer is used to program your device back to its regular settings after the scan. With either method, your device is placed back to its regular settings.

    Your MR conditional pacemaker is designed to give your heart the support it needs, in addition to ensuring you can receive the best in diagnostic imaging in the future should that need arise. Your doctor is the best source of information about your total overall health. It is important to discuss any questions or concerns you might have with him or her.

  • WHAT DOES THE WIRELESS REMOTE MONITORING FEATURE OF THIS PRODUCT DO?
    Wireless remote monitoring provides communication between your device, a transmitter in your home and a secure website at your hospital or clinic. The wireless communication allows your doctor to monitor your pacemaker’s performance and changes to your cardiac rhythm without a doctor visit.
  • IS IT SAFE TO PASS THROUGH METAL DETECTORS AND AIRPORT SECURITY SYSTEMS WITH A PACEMAKER? 
    It is considered safe to pass through a metal detector and airport security system. Walk through the systems at your normal walking rate. When security personnel perform a search with a handheld wand, request that the search be done quickly and that the wand be held over your pacemaker for no more than a second.
  • WHAT EXERCISES ARE SAFE WITH A PACEMAKER?
    Talk to your doctor about your activities, especially about vigorous or strenuous exercise, but exercise and activity are healthy parts of life with a pacemaker.
  • CAN I USE A CELL PHONE WITH A PACEMAKER?

    Cellular phones send electromagnetic signals, which can interfere with your pacemaker. You can minimize the risk by taking simple precautions, like:

    • Not carrying the cell phone in a pocket or bag over the pacemaker
    • Holding the cell phone to the ear furthest from the pacemaker

    Abbott currently has put special filters in our pacemakers to prevent cell phone interference. Learn more about electromagnetic interference.

Find answers to more frequently asked questions.

SAFETY AND USE

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Find important safety and use information for our implantable devices and systems.

FAQS

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Find answers to your questions about cardiac arrhythmias.
IMPORTANT SAFETY INFORMATION

INDICATIONS AND IMPORTANT SAFETY INFORMATION

Assurity MRI™

Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Devices depicted may not be available in all countries. Check with your St. Jude Medical representative for product availability in your country.

Indications: : Implantation is indicated in one or more of the following permanent conditions: syncope, presyncope, fatigue, disorientation due to arrhythmia/bradycardia or any combination of those symptoms. Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. Dual-Chamber Pacing is indicated for those patients exhibiting: sick sinus syndrome, chronic, symptomatic second- and third-degree AV block, recurrent Adams-Stokes syndrome, symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out. Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems. Ventricular Pacing is indicated for patients with significant bradycardia and normal sinus rhythm with only rare episodes of A-V block or sinus arrest, chronic atrial fibrillation, severe physical disability. AF Suppression algorithm is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications.

Contraindications:Dual-chamber pulse generators are contraindicated in patients with an implanted cardioverter-defibrillator. Rate-Adaptive Pacing may be inappropriate for patients who experience angina or other symptoms of myocardial dysfunction at higher sensor-driven rates. An appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient. AF Suppression™ stimulation is not recommended in patients who cannot tolerate high atrial-rate stimulation. Dual-Chamber Pacing, though not contraindicated for patients with chronic atrial flutter, chronic atrial fibrillation, or silent atria, may provide no benefit beyond that of single-chamber pacing in such patients. Single-Chamber Ventricular Demand Pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction, or suffer a drop in arterial blood pressure with the onset of ventricular pacing. Single-Chamber Atrial Pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction.

Potential Adverse Events: Dual-chamber pulse generators are contraindicated in patients with an implanted cardioverter-defibrillator. Rate-Adaptive Pacing may be inappropriate for patients who experience angina or other symptoms of myocardial dysfunction at higher sensor-driven rates. An appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient. AF Suppression™ stimulation is not recommended in patients who cannot tolerate high atrial-rate stimulation. Dual-Chamber Pacing, though not contraindicated for patients with chronic atrial flutter, chronic atrial fibrillation, or silent atria, may provide no benefit beyond that of single-chamber pacing in such patients. Single-Chamber Ventricular Demand Pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction, or suffer a drop in arterial blood pressure with the onset of ventricular pacing. Single-Chamber Atrial Pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction.

Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.

SJM-CV WEB-0718-0080a

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Information contained herein for distribution outside the U.S. only.

CAUTION: These products are intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or online for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.
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