Brief Statement MRI Access

SureScan Portfolio for 1.5T and 3T MR Conditional Use

Medtronic SureScan^™ products and systems are MR-conditional, and as such are designed to allow patients to undergo MRI under the specified conditions for use.

Pacing, ICD, CRT-P and CRT-D systems: When programmed to On, the MRI SureScan feature allows the patient to be safely scanned while the device continues to provide appropriate pacing. A complete transvenous SureScan system, which is a SureScan device with appropriate SureScan lead(s), is required for use in the MR environment. For ICD and CRT-D systems, when a single-coil SureScan defibrillation lead is used, a Medtronic DF-1 pin plug must be secured in the SVC port to make a complete SureScan DF-1 defibrillation system. To verify that components are part of a SureScan system, visit http://www.mrisurescan.com/. Any other combination may result in a hazard to the patient during an MRI scan.

Indications

The SureScan MRI transvenous pacing systems are indicated for rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity. Dual chamber SureScan pacing systems are also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony.

The SureScan MRI defibrillation systems are indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. In addition, the dual chamber devices are indicated for use in the above patients with atrial tachyarrhythmias, or those patients who are at significant risk of developing atrial tachyarrhythmias. 

The SureScan MRI CRT-D systems are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias and for providing cardiac resynchronization therapy in heart failure patients on stable, optimal heart failure medical therapy if indicated, and meet any of the following classifications: ●New York Heart Association (NYHA) Functional Class III or IV and who have a left ventricular ejection fraction ≤ 35% and a prolonged QRS duration, ●Left bundle branch block (LBBB) with a QRS duration ≥ 130 ms, left ventricular ejection fraction ≤ 30%, and NYHA Functional Class II, ●NYHA Functional Class I, II, or III and who have left ventricular ejection fraction ≤ 50% and atrioventricular block (AV block) that are expected to require a high percentage of ventricular pacing that cannot be managed with algorithms to minimize right ventricular pacing. Optimization of heart failure medical therapy that is limited due to AV block or the urgent need for pacing should be done post implant. Claria/Amplia only: Some CRT-D system are also indicated for use in patients with atrial tachyarrhythmias, or those patients who are at significant risk for developing atrial tachyarrhythmias.

The SureScan CRT-P Systems are indicated for: NYHA Functional Class III and IV patients who remain symptomatic despite stable, optimal heart failure medical therapy and have a LVEF ≤ 35% and a prolonged QRS duration and for NYHA Functional Class I, II, or III patients who have a LVEF ≤ 50%, are on stable, optimal heart failure medical therapy if indicated and have atrioventricular block (AV block) that are expected to require a high percentage of ventricular pacing that cannot be managed with algorithms to minimize right ventricular pacing. Optimization of heart failure medical therapy that is limited due to AV block or the urgent need for pacing should be done post implant. Rate adaptive pacing is provided for those patients developing a bradycardia indication who might benefit from increased pacing rates concurrent with increases in activity. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony. Antitachycardia pacing (ATP) is indicated for termination of atrial tachyarrhythmias in patients with one or more of the above pacing indications.

Micra^™ Model MC1VR01 is indicated for patients with symptomatic paroxysmal or permanent high grade AV block in the presence of AF. It is also indicated in the absence of AF as an alternative to dual chamber pacing, or symptomatic bradycardia-tachycardia syndrome or sinus node dysfunction (sinus bradycardia/sinus pauses) when atrial lead placement is considered difficult, high risk, or not deemed necessary for effective therapy.

The Reveal LINQ^™ insertable cardiac monitor (ICM) is an implantable patient-activated and automatically-activated monitoring system that records subcutaneous ECG and is indicated for patients with clinical syndromes or situations at increased risk of cardiac arrhythmias, or patients who experience transient symptoms such as dizziness, palpitation, syncope and chest pain that may suggest a cardiac arrhythmia.

Contraindications

The SureScan transvenous pacing and CRT-P systems are contraindicated for implantation with unipolar pacing leads (Revo MRI^™ only), concomitant implantation with another bradycardia device or an implantable cardioverter defibrillator.

Micra IPG is contraindicated for patients who have the following types of medical devices implanted: an implanted device that would interfere with the implant of the Micra device in the judgment of the implanting physician, an implanted inferior vena cava filter, a mechanical tricuspid valve, or an implanted cardiac device providing active cardiac therapy that may interfere with the sensing performance of the Micra device or for patients who have the following conditions: femoral venous anatomy unable to accommodate a 7.8 mm (23 French) introducer sheath or implant on the right side of the heart (for example, due to obstructions or severe tortuosity), morbid obesity that prevents the implanted device from obtaining telemetry communication within ≤ 12.5 cm (4.9 in), or known intolerance to the materials listed in the Instruction for Use, or to heparin, or sensitivity to contrast media that cannot be adequately pre-medicated.

SureScan defibrillation and CRT-D systems are contraindicated for patients experiencing tachyarrhythmias with transient or reversible causes, or patients with incessant VT or VF. For dual chamber and CRT-D devices, the device is contraindicated for patients whose primary disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF. For single chamber devices, the device is contraindicated for patients whose primary disorder is atrial tachyarrhythmia.

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

Warnings and Precautions

Changes in a patient's disease and/or medications may alter the efficacy of the device’s programmed parameters. Patients should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection, inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia, device electrical reset, or device damage. Do not place transthoracic defibrillation paddles directly over the device. Additionally, for CRT-D devices, certain programming and device operations may not provide cardiac resynchronization. Use of the device should not change the application of established anticoagulation protocols.

Patients and their implanted systems must be screened to meet the following requirements for MRI:

• SureScan transvenous systems: no lead extenders, lead adaptors or abandoned leads present; no broken leads or leads with intermittent electrical contact as confirmed by lead impedance history; and the system must be implanted in the left or right pectoral region. For pacemaker-dependent patients, it is not recommended to perform an MRI scan if the right ventricular (RV) lead pacing capture threshold is greater than 2.0 V at 0.4 ms. A higher pacing capture threshold may indicate an issue with the implanted lead. No diaphragmatic stimulation at a pacing output of 5.0 V and at a pulse width of 1.0 ms in patients whose device will be programmed to an asynchronous pacing mode when MRI SureScan is on. It is not recommended to perform MRI scans during the lead maturation period (approximately 6 weeks).
• SureScan Pacemaker and CRT-P specific: pace polarity parameters set to Bipolar for programming MRI SureScan to On (Advisa^™ MRI and CRT-P [atrial and RV] only); or a SureScan pacing system with a lead impedance value of ≥ 200 Ω and ≤ 1500 Ω (Advisa MRI and Revo MRI only). Revo MRI patients must have pacing capture thresholds of ≤ 2.0 V at a pulse width of 0.4 ms and a SureScan pacing system that has been implanted for a minimum of 6 weeks.
• Micra: no abandoned leads are present; device is operating within the projected service life; pacing amplitude is ≤ 4.5 V at the programmed pulse width; no diaphragmatic stimulation is observed when MRI SureScan is programmed to On.

MR Scanning Conditions:

Micra, Reveal LINQ, and transvenous system patients may be scanned using a horizontal field, cylindrical bore, clinical 1.5T or 3T MRI system for hydrogen proton imaging. Revo MRI pacemakers can only be scanned using 1.5T systems.

Potential Adverse Events

Potential complications include, but are not limited to, rejection phenomena, device migration, infection, or erosion through the skin. Potential complications associated with cardiac rhythm devices include muscle or nerve stimulation, oversensing, failure to detect and/or terminate arrhythmia episodes, acceleration of tachycardia, and surgical complications such as hematoma, inflammation, and thrombosis. Potential lead complications include, but are not limited to, valve damage, fibrillation, thrombosis, thrombotic and air embolism, cardiac perforation, heart wall rupture, cardiac tamponade, pericardial rub, infection, myocardial irritability, and pneumothorax. Other potential complications related to the lead may include lead dislodgement, lead conductor fracture, insulation failure, threshold elevation, or exit block. Other potential complications related to Micra are access site hematoma, AV fistulae, and vessel spasm, Potential MRI complications include, but are not limited to, lead electrode heating and tissue damage resulting in loss of sensing or capture or both, or MR-induced stimulation on leads resulting in continuous capture, VT/VF, and/or hemodynamic collapse. Potential complications of the Reveal LINQ device include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin.

See the appropriate product MRI SureScan Technical Manual before performing an MRI Scan and see the device manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com or www.mrisurescan.com.

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

Reveal XT Insertable Cardiac Monitor and Paitent Assistant

Indications

9529 Reveal™ XT Insertable Cardiac Monitor

The Reveal XT insertable cardiac monitor is an implantable patient-activated and automatically 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.

9539 Reveal™ XT Patient Assistant

The Reveal XT Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates one or more of the data management features in the Reveal insertable cardiac monitor:

• To verify whether the implanted device has detected a suspected arrhythmia or device related event.
• To initiate recording of cardiac event data in the implanted device memory.

Contraindications

There are no known contraindications for the implant of the Reveal XT insertable cardiac monitor. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated. 

Warnings/Precautions

9529 Reveal XT Insertable Cardiac Monitor

Patients with the Reveal XT insertable cardiac monitor 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. MRI scans should be performed only in a specified MR environment under specified conditions as described in the device manual. 9539 Reveal XT Patient Assistant Operation of the Model 9539 Patient Assistant near sources of electromagnetic interference, such as cellular phones, computer monitors, etc., may adversely affect the performance of this device. 

Potential Complications

Potential complications include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin. See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. 

See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at www.medtronic.com.