075802

Indications, Safety, and WarningsIndicationsRadiofrequency (RF) catheters are indicated for use with the Medtronic RF generator to deliver RF energy for intracardiac ablation of accessory atrioventricular (AV) conduction pathways associated with tachycardia for the treatment of AV nodal re-entrant tachycardia and for creation of complete AV block in patients with a difficult to control ventricular response to an atrial arrhythmia.Contraindications The use of this device is contraindicated in patients with active systemic infection. The transseptal approach is contraindicated in patients with left atrial thrombus or myxoma, or interatrial baffle or patch. The retrograde transaortic approach is contraindicated in patients with aortic valve replacement.Warnings and precautions Do not attempt to operate the Medtronic ablation system or connect the ablation catheter to a Medtronic RF generator prior to completely reading and understanding the Medtronic ablation system technical manual and the ablation catheter instructions for use. Use the catheter with only a Medtronic RF generator, accessories, and cables. The safety and use with other RF generators or accessories has not been tested. Use only isolated amplifiers, pacing equipment, and ECG equipment or patient injury or death may occur. Leakage current from any connected device to the patient must not exceed 10 micro Amps. The catheter should be used only by or under the supervision of physicians well trained in electrophysiology, including the placement and use of intracardiac electrode catheters, and experienced in performing RF catheter ablation procedures. Cardiac ablation procedures should be performed only in a fully equipped electrophysiology laboratory.Potential complications Potential complications include, but are not limited to, pulmonary embolism; myocardial infarction; cerebrovascular accident; cardiac damage, perforation, and tamponade; perforation of the vasculature; partial or complete AV block; and death. Due to the X-ray beam intensity and the duration of the fluoroscopic imaging during ablation procedures, patients and laboratory staff may be subjected to acute radiation injury and increased risk for somatic and genetic effects. Catheters with distal pair electrode spacing greater than 2 mm should not be used in the ablation of septal accessory pathways or in the treatment of AV nodal re-entrant tachycardia because of the potential for creating inadvertent complete AV block. Implanted devices such as pacemakers and implantable cardioverter-defibrillators (ICDs) may be adversely affected by RF energy. Catheter materials are not compatible with magnetic resonance imaging (MRI).See the device manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at www.medtronic.com. Caution: Federal law (United States) restricts these devices to sale by or on the order of a physician. MAJ_83945

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