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:
Adverse Events: Potential adverse events include: cardiac tamponade, hemorrhage, pneumothorax, air embolism, venous thrombosis and/or obstruction, tissue necrosis, tricuspid valve dysfunction, infection.
MAT-2011148 v1.0