Durata

Indications, Safety & Warnings

Durata

Family of Defibrillation Leads

Rx Only

Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Indications and Usage: The Durata lead is intended for permanent sensing and pacing of the right ventricle and the delivery of cardioversion/defibrillation therapy when used with a compatible Abbott pulse generator.

Contraindications: Durata leads are contraindicated in the following:

• Patients with tricuspid valvular disease or a mechanical tricuspid valve.
• Patients with ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction.
• Patients for whom a single dose of 1.0 mg of dexamethasone sodium phosphate is contraindicated.
• For use with extra firm (red color knob) stylets.

Adverse Events: Potential adverse events include: cardiac tamponade, hemorrhage, pneumothorax, air embolism, venous thrombosis and/or obstruction, tissue necrosis, tricuspid valve dysfunction, infection.