Brief statement for Aurora EV-ICD™ MRI SureScan™ system and associated tunneling tools
Indications
Device: The Aurora EV-ICD™ MRI SureScan™ Model DVEA3E4 device is indicated for the automated treatment of patients who have experienced, or are at significant risk of developing, life-threatening ventricular tachyarrhythmias through the delivery of antitachycardia pacing, cardioversion, and defibrillation therapies. Medical conditions that may indicate a patient for an EV-ICD for primary or secondary prevention of sudden cardiac death due to life-threatening ventricular tachyarrhythmias include: previous ventricular tachyarrhythmias, coronary disease with left ventricular dysfunction, cardiomyopathy, inherited primary arrhythmia syndromes, and congenital heart disease.
Note: For patient-specific recommendations regarding indications for primary and secondary prevention of sudden cardiac death, refer to current clinical guidelines from the European Society of Cardiology (ESC), American Heart Association (AHA), American College of Cardiology (ACC), and Heart Rhythm Society (HRS).
Lead: The Epsila EV™ MRI SureScan™ Model EV2401 extravascular lead is indicated for use in the anterior mediastinum for pacing therapies, cardioversion, and defibrillation when an extravascular implantable cardioverter defibrillator is indicated to treat patients who have experienced, or are at significant risk of developing, life-threatening ventricular tachyarrhythmias.
Tunneling Tools: The Epsila EV™ Model EAZ101 sternal tunneling tool is indicated for use in the implant of a compatible anterior mediastinum defibrillation lead.
The Epsila EV™ Model EAZ201 transverse tunneling tool is indicated for use in the implant of a compatible anterior mediastinum defibrillation lead.
MR Conditions for Use
The Aurora EV-ICD MRI SureScan 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 MR conditions for use. A complete SureScan system is required for use in the MR environment. Before performing an MR scan, refer to the MRI technical manual for MRI-specific warnings and precautions. When programmed to On, the MRI SureScan feature allows the patient to be safely scanned. A complete SureScan system includes a SureScan extravascular ICD device (Model DVEA3E4) with a SureScan extravascular lead (Model EV2401). 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.
Contraindications
The Aurora EV-ICD MRI SureScan Model DVEA3E4 device is contraindicated for use in the following situations:
- If implanted with a unipolar pacemaker, a device delivering dual-chamber or triple-chamber pacing, and/or a device delivering antitachyarrhythmia therapies
- If incessant ventricular tachycardia (VT) or ventricular fibrillation (VF) exists
- If the patient’s primary disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF
- If symptomatic bradycardia exists
- If tachyarrhythmias with transient or reversible causes exist
The Epsila EV MRI SureScan Model EV2401 lead is contraindicated for any application that is not specified in the Indications.
The Epsila EV Model EAZ101 sternal tunneling tool is contraindicated for use in patients with a prior sternotomy.
The Epsila EV Model EAZ201 transverse tunneling tool is contraindicated for any application that is not specified in the Indications.
Warnings and Precautions
Device and Lead: It is important to read the Aurora EV-ICD MRI Technical Manual before conducting an MRI scan on a patient with an implanted SureScan system. The MRI SureScan feature permits a mode of operation that allows a patient with a SureScan system to be safely scanned by an MRI machine. When programmed to On, MRI SureScan operation disables arrhythmia detection and all user-defined diagnostics. Do not scan a patient without first programming the MRI SureScan mode to On. Scanning the patient without programming the MRI SureScan mode On may result in patient harm or damage to the SureScan system.
Patients and their implanted systems must be screened to meet the following requirements for MRI: no implanted 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 Sure Scan device must be operating within the projected service life; the device does not provide pacing therapy when SureScan mode is programmed On. Do not scan pacemaker-dependent patients. MRI scans during the lead maturation period have not been prospectively studied by Medtronic and are not recommended. If scanning a patient with multiple devices, ensure all devices meet the MRI labeling conditions.
Use only the Epsila EV MRI SureScan Model EV2401 extravascular lead with a Medtronic EV4 implantable cardioverter defibrillator system. The known potential adverse consequences of using any other combination may include undersensing of cardiac activity, failure to deliver necessary therapy, or an intermittent electrical connection. All can present serious risks for adverse events to the patient. The EV4 connector is a Medtronic proprietary design, not an industry standard. No claims of safety and efficacy can be made with regard to devices that are not labeled as EV4 by Medtronic.
Pre-implant consideration for concomitant implant with a neurostimulator and cardiac device implants: Some patients have medical conditions that require the implant of both a neurostimulator and a cardiac device (for example, a pacemaker, a defibrillator, or a monitor). In this case, physicians involved with either device should contact Medtronic Technical Services or their Medtronic representative before implanting the patient with the second device. Based on the particular devices that the physicians have prescribed, Medtronic can provide the necessary precautions and warnings related to the implant procedure.
Use of the DVEA3E4 device has not been evaluated in patients who have undergone a prior sternotomy.
The DVEA3E4 device has not been tested specifically for pediatric use.
Use of the EV2401 lead has not been evaluated in patients who have undergone a prior sternotomy. Performing a sternotomy on a patient with an implanted lead has not been evaluated.
Do not implant the EV2401 lead using any tools other than the Medtronic tunneling tools designed for implanting the extravascular ICD system.
Tunneling Tools: The tunneling tools have not been tested for use with non-Medtronic products or for pediatric use.
Use of the EAZ201 transverse tunneling tool have not been evaluated in patients who have undergone a prior sternotomy.
Potential Adverse Events
Implant and usage of this system may result in adverse events, which may lead to injury, death, or other serious adverse reactions. Potential adverse events include, but are not limited to acute tissue trauma, allergic reaction, bradyarrhythmia, cardiac arrest, cardiac inflammation, cardiac perforation, cardiac tamponade, death, device migration, discomfort, dizziness, dyspnea, erosion, extracardiac stimulation, fever, hematoma, hemorrhage, hemothorax, hiccups, hospitalization, inappropriate shock, infection, insulation failure, lead abrasion, lead fracture, lead migration or dislodgement, lethargy, mental anguish, organ damage (liver, mammary arteries, diaphragmatic arteries), pain, palpitations, pericardial effusion, pericarditis, pneumothorax, return of cardiac symptoms, seroma, syncope, tachyarrhythmia, toxic reaction, and wound dehiscence.
Potential MRI adverse events include the following: lead electrode heating resulting in tissue damage near the lead electrodes or patient discomfort or both; spontaneous tachyarrhythmia occurring during the scan that is not detected and treated because tachyarrhythmia detection is suspended while MRI SureScan mode is programmed to On; device heating resulting in tissue damage in the implant pocket or patient discomfort or both; MR-induced muscle stimulation resulting in patient discomfort; damage to the device or lead causing the system to fail to detect or treat irregular heartbeats or causing the system to treat the patient’s condition incorrectly; damage to the functionality or mechanical integrity of the device resulting in the inability of the device to communicate with the programmer; and movement or vibration of the device or leads resulting in dislodgment.
See the Aurora EV-ICD MRI SureScan technical manual before performing an MRI Scan, and the device, lead and tunneling tools manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. Refer to the Medtronic Manual Library website www.medtronic.com/manuals. For further information, please 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.