CARDIOVASCULAR
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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.

MAT-2011148 v1.0

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DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.