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Visia AF MRI SureScan

Implantable Cardioverter Defibrillators (ICDs)

Brief statements:

Visia AF MRI VR DVFB1D4

The Visia AF MRI VR SureScan ICD 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. The Visia AF MRI SureScan system automatically detects and records the occurrence of atrial fibrillation (AF) for diagnostic purposes.

Indications for Use

The Visia AF MRI VR SureScan system is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

A complete SureScan defibrillation system is required for use in the MR environment. A complete SureScan defibrillation system includes a Visia AF MRI VR SureScan ICD device with a SureScan defibrillation lead. 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 Visia AF MRI VR SureScan ICD 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; patients who have a unipolar pacemaker implanted, patients with incessant VT or VF, and patients whose primary disorder is atrial tachyarrhythmia.

Warnings and Precaution

Changes 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 MRI system with operating frequency of 64MHz, maximum spatial gradient ≤ 20 T/m, and maximum gradient slew rate performance per axis ≤ 200 T/m/s. Scanner must be operated in Normal Operating Mode (whole body averaged specific absorption rate (SAR) ≤ 2.0 W/kg, head SAR ≤ 3.2 W/kg).

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.

Potential MRI complications for the SureScan system include, but are not limited to, lead electrode heating and tissue damage resulting in loss of sensing or capture or both, or induced currents on leads resulting in continuous capture, VT/VF, and/or hemodynamic collapse; spontaneous tachyarrhythmia occurring during the scan that is not detected and treated because tachyarrhythmia detection is suspended while MRI SureScan is programmed to On; potential for VT/VF induction when the patient is programmed to an asynchronous pacing mode during MRI SureScan; device heating resulting in tissue damage in the implant pocket or patient discomfort or both; or damage to the functionality or mechanical integrity of the device resulting in the inability of the device to communicate with the programmer.

See the MRI SureScan Technical Manual before performing an MRI Scan and 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 Medtronic’s website at www.medtronic.com or www.mrisurescan.com.

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