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:
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.
MAT-2012010 v1.0