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Visia AF VR

Implantable Cardioverter Defibrillators (ICDs)

Brief statements:

Visia AF VR Models DVAB1D1 and Visia AF VR Model DVAB1D4

Indications

The Visia AF VR ICD system is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Note: The ICD features of the device functions the same as other approved Medtronic market-released ICDs.

AF Detection Feature

The Visia AF VR ICD system automatically detects and records the occurrence of atrial fibrillation (AF) for diagnostic purposes. The AF Detection feature analyzes variability in the ventricular rate to determine whether the patient is currently experiencing atrial fibrillation. Evidence of atrial fibrillation is based on ventricular rate variability assessed via a Lorenz plot.

Contraindications

The Visia AF VR ICD 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; patients who have a unipolar pacemaker implanted, patients with incessant VT or VF, and patients whose primary disorder is atrial tachyarrhythmia.

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.

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.

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 Medtronic’s website at www.medtronic.com.

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