DTPC2Q1

Crome™ HF cardiac resynchronization therapy device (CRT-D) with MRI SureScan™

Indications, Safety, and WarningsIndications
The Cobalt™ XT, Cobalt™, and Crome™ HF CRT-D MRI SureScan™ systems are indicated for use in patients who are at significant risk of developing atrial and/or life-threatening ventricular arrhythmias and who have heart failure with ventricular arrhythmias. Heart failure patients must have experienced one or more of the following conditions:

NYHA Functional Class III or IV patients who remain symptomatic despite stable, optimal medical therapy and have LVEF ≤ 35% and a prolonged QRS duration

NYHA Functional Class II patients who have left bundle-branch block (LBBB) with a QRS duration ≥ 130 ms and a left ventricular ejection fraction ≤ 30%

NYHA Functional Class I, II, or III who are on stable, optimal medical therapy (if indicated), and have LVEF ≤ 50%, atrioventricular block (AV block), and are expected to require a high percentage of ventricular pacing that cannot be managed with algorithms to minimize right ventricular pacing

The Cobalt™ XT, Cobalt™, and Crome™ VR and DR implantable cardiac device (ICD) MRI SureScan™ systems are indicated for the automated treatment of patients who have experienced, or are at significant risk of developing, atrial and/or life-threatening ventricular arrhythmias through the delivery of antitachycardia pacing, cardioversion, and defibrillation therapies.MRI conditions for useMedtronic SureScan™ implantable cardiac device (ICD) and CRT-D systems are MR Conditional, and as such are designed to allow patients to undergo MRI under the specified conditions for use. Implantable cardiac device (ICD) and CRT-D SureScan™ system patients may be scanned using a horizontal field, cylindrical bore, clinical 1.5T or 3T MRI system for hydrogen proton imaging. 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 SureScan™ defibrillation system, which is a SureScan™ device with appropriate SureScan™ lead(s), is required for use in the MR environment. Any other combination may result in a hazard to the patient during an MRI scan.ContraindicationsThe Cobalt™ XT, Cobalt™, and Crome™ VR and DR implantable cardiac device (ICD) and CRT-D MRI SureScan™ systems are contraindicated for use in the following situations:

If implanted with a unipolar pacemaker

If incessant ventricular tachycardia (VT) or ventricular fibrillation (VF) exists

If the primary disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF

If tachyarrhythmias with transient or reversible causes exist, including the following known issues: acute myocardial infarction, drug intoxication, drowning, electric shock, electrolyte imbalance, hypoxia, and sepsis

Warnings and precautionsChanges 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. Patients and their implanted systems must be screened to meet the following requirements for MRI: no lead extenders, lead adaptors, or abandoned leads present; no broken leads or leads with intermittent electrical contact as confirmed by lead impedance history. The device must be operating within the projected service life, and the system must be implanted in the left or right pectoral region.Potential adverse eventsPotential adverse events include, but are not limited to, the following events: allergic reactions, atrial fibrillation, bradyarrhythmia, cardiac arrest, device migration, discomfort, dizziness, dyspnea, erosion, excessive fibrotic tissue growth, heart failure or loss of CRT (for CRT-D patients), hematoma, hemorrhage, inability to deliver therapy, inappropriate shock, infection, lead migration/dislodgement, lethargy, loss of pacing, mental anguish, necrosis, nerve damage, oversensing, palpitations, seroma, syncope, tachyarrhythmia, tissue damage due to heating of the device, undersensing, and wound dehiscence. Potential MRI complications include, but are not limited to, lead electrode heating and tissue damage resulting in loss of sensing or capture or both, spontaneous tachyarrhythmia, potential for VT/VF induction, device heating that results in tissue damage, stimulation of the leads that results in continuous capture, VT/VF, hemodynamic collapse, damage to the device or the leads, causing the system to fail or treat the patient’s condition incorrectly, and movement or vibration of the device or the leads, resulting in dislodgement.See the device manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and adverse events. See the MRI SureScan™ technical manual before performing an MRI scan.Caution: Federal law (United States) restricts these devices to sale by or on the order of a physician.MAJ_83960

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Customer Care Team