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Temporary Transvenous Pacing Lead

Model 6416

Indications, Safety, and Warnings

Contraindications

Patients with sepsis or a hypercoagulable state. Patients with a mechancial valve in the tricuspid position should not be considered for ventricular placement.

Warnings

An inserted lead forms a direct current path to the myocardium. During lead insertion and testing, use only battery-powered equipment or line-powered equipment specifically designed for this purpose, to protect against fibrillation that may be caused by alternating currents. Line-powered equipment used in the vicinity of the patient must be properly grounded. Lead connector pins must be insulated from any leakage currents that may arise from line-powered equipment.

Potential Complications

Arrhythmias, endocarditis, pneumothorax, cardiac perforation, cardiac tamponade, muscle or nerve stimulation, sepsis/infection, thrombosis, atriovenous fistula formation, damage to vessel or valve structures, lead dislodgement.

Precautions

Do not severely bend, kink, or stretch the lead or guide catheter, and do not grip with surgical instruments or use excessive force during insertion. Do not wipe the lead with chlorofluorocarbon-based (CFC) solvents.

Inspect the sterile package before opening. If the seal or package is damaged, contact your local Medtronic representative. The product should not be exposed to temperatures 70º C (158º F).