Implantable cardioverter defibrillators

Evera™ ICD

<p>Evera MRI™ SureScan™ ICDs allow access to full-body MRI scans.</p>

Indications, Safety, and WarningsThe Evera MRI™ SureScan™ defibrillation system is MR Conditional and, as such, is designed to allow patients to be safely scanned by an MRI machine when used according to the specified MRI conditions for use. When programmed to "on," the MRI SureScan™ feature allows the patient to be safely scanned while the device continues to provide appropriate pacing.
Indications for use The Evera MRI™ SureScan™ defibrillation system is 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 ICD features of the device function the same as other approved Medtronic market-released ICDs. The following notes are applicable based on the features available in the specific Evera MRI™ model. 

The use of the device has not been demonstrated to decrease the morbidity related to atrial tachyarrhythmias.

The effectiveness of high-frequency burst pacing (atrial 50 Hz burst therapy) in terminating device classified atrial tachycardia (AT) was found to be 17%, and in terminating device classified atrial fibrillation (AF) was found to be 16.8% in the ventricular tachycardia (VT)/AT patient population studied.

The effectiveness of high-frequency burst pacing (atrial 50 Hz burst therapy) in terminating device classified atrial tachycardia (AT) was found to be 11.7%, and in terminating device classified atrial fibrillation (AF) was found to be 18.2% in the AF-only patient population studied.

A complete SureScan™ defibrillation system is required for use in the MR environment, which is an Evera MRI™ SureScan™ ICD device with a SureScan™ defibrillation lead in the right ventricle and if using a dual-chamber ICD, a SureScan™ atrial pacing lead. 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 mrisurescan.com. Any other combination may result in a hazard to the patient during an MRI scan.Contraindications The Evera MRI™ SureScan™ system is contraindicated for patients experiencing tachyarrhythmias with transient or reversible causes including, but not limited to, the following: acute myocardial infarction, drug intoxication, drowning, electric shock, electrolyte imbalance, hypoxia, or sepsis. The device is contraindicated for patients who have a unipolar pacemaker implanted. The device is contraindicated for patients with incessant VT or VF. For dual-chamber 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. Warnings and precautionsChanges in 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 implanted lead extenders, lead adaptors, or abandoned leads; no broken leads or leads with intermittent electrical contact as confirmed by lead impedance history; a SureScan™ defibrillation system implanted in the left or right pectoral region; pacing capture thresholds of ≤ 2.0 V at a pulse width of 0.4 ms; 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 programmed to "on."Patients may be scanned using a horizontal field, cylindrical bore, clinical 1.5T or 3T MRI system for hydrogen proton imaging, maximum spatial gradient ≤ 20 T/m, and maximum gradient slew rate performance per axis ≤ 200 T/m/s. 1.5T scanners must be operated in "normal operating mode" (whole body averaged specific absorption rate (SAR) ≤ 2.0 W/kg, head SAR ≤ 3.2 W/kg). 3T scanners must be operated in "first level controlled operating mode" or "normal operating mode". B1+RMS must be ≤ 2.8 μT when the isocenter (center of the bore) is inferior to the C7 vertebra. Scans can be performed without B1+RMS  restriction when the isocenter is at or superior to the C7 vertebra. Continuous patient monitoring is required while MRI SureScan™ is programmed to "on." While MRI SureScan™ is programmed to "on," arrhythmia detection and therapies are suspended, leaving the patient at risk of death from untreated spontaneous tachyarrhythmia. In addition, if the device is programmed to an asynchronous pacing mode, arrhythmia risk may be increased.Potential complications Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle, or nerve stimulation, oversensing, failure to detect and/or terminate tachyarrhythmia episodes, acceleration of ventricular tachycardia, and surgical complications such as hematoma, infection, inflammation, and thrombosis. Other potential complications related to the lead may include lead dislodgement, lead conductor fracture, insulation failure, threshold elevation, or exit block.The SureScan™ system has been designed to minimize potential complications in the MRI environment. 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. See the MRI SureScan™ technical manual before performing an MRI scan and device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events.Caution: Federal law (United States) restricts this device to sale by or on the order of a physician.

Features

MR Conditional with PhysioCurve™ design
SmartShock™ 2.0 technology
OptiVol™ 2.0 fluid status monitoring
Complete capture management™

Product details

Projected Longevity^†

Dual-chamber — 9.7 years¹
Single-chamber — 11 years²

Ordering information

Item number	Description	Mass (g)	Volume (mL)	Size — height × width × depth (mm)
DVMB2D1	Evera MRI XT SureScan -dual chamber, IS-1 / DF-1	77	33	66 x 51 x 13
DVMB2D4	Evera MRI XT SureScan -single chamber, DF4	77	34	64 x 51 x 13
DVMC3D1	Evera MRI S SureScan -dual chamber, IS-1 / DF-1	77	33	66 x 51 x 13
DVMC3D4	Evera MRI S SureScan - single chamber, DF-4	77	33	64 x 51 x 13
DDMB2D1	Evera MRI XT SureScan -single chamber, DF-1	77	33	66 x 51 x 13
DDMC3D1	Evera MRI S SureScan -dual chamber, IS-1 / DF-1	77	33	66 x 51 x 13
DDMC3D4	Evera MRI S SureScan -dual chamber, IS-1 / DF-4	78	34	68 x 51 x 13
DDMB2D4	Evera MRI XT SureScan -dual chamber, IS-1 / DF-4	77	33	64 x 51 x 13

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† Projected life is based on VVI for VR and DDD for DR devices with 0% pacing from the manuals of the Evera MRI™ models listed.1 The Evera MRI™ S and XT models share the same battery, telemetry, and programming features that impact longevity.

‡ Limited lifetime warranty, some restrictions may apply. The limited lifetime warranty applies to the performance of the device and includes some reimbursement to patients of unreimbursed medical expenses. The warranty is limited to the provisions in the written limited warranty document that accompanies each product. Consult the written limited warranty document for details, a copy of which will be provided upon request.

Evera MRI™ XT DR SureScan™ DDMB1D4 device manual. Projected service life. 2019:31. manuals.medtronic.com
Evera MRI™ XT VR SureScan™ DVMB1D4 device manual. Projected service life. 2109:27. manuals.medtronic.com

Evera™ ICD

Features

Product details

Ordering information

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