Quartet

Indications, Safety & Warnings

Quartet LV Lead

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 Quartet LV lead is intended for permanent sensing and pacing of the left ventricle when used with a compatible Abbott biventricular system.

Contraindications: The use of the Quartet LV lead is contraindicated in patients who:

• Are expected to be hypersensitive to a single dose of 1.0 mg of dexamethasone sodium phosphate.
• Are unable to undergo an emergency thoracotomy procedure.
• Have coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.

Adverse Events: Potential adverse events associated with the use of left ventricular leads include: cardiac/coronary sinus dissection, cardiac/coronary sinus perforation, cardiac tamponade, coronary sinus or cardiac vein thrombosis, death, endocarditis, excessive bleeding, hematoma/seroma, induced atrial or ventricular arrhythmias, infection, lead dislodgment, local tissue reaction, formation of fibrotic tissue, myocardial irritability, myopotential sensing, pectoral/diaphragmatic/phreni c nerve stimulation, pericardial effusion, pericardial rub, pneumothorax/hemothorax, pulmonary edema, thrombolytic or air embolism, valve damage.