Quartet

Important Safety Information

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™ leads are 5.1 French, transvenous, steroid eluting, quadripolar, IS4 compatible (single connector with four electrical terminals), passive fixation leads intended for permanent sensing and pacing of the left ventricle when used with a compatible Abbott Medical biventricular system with an IS4‑LLLL lead receptacle designation.

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: Allergic reaction to contrast media, Body rejection phenomena, 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, Loss of pacing and/or sensing due to dislodgment or mechanical malfunction of the pacing lead, Myocardial irritability, Myopotential sensing, Pectoral/diaphragmatic/phrenic nerve stimulation, Pericardial effusion, Pericardial rub, Pneumothorax/hemothorax, Prolonged exposure to fluoroscopic radiation, Pulmonary edema Renal failure from contrast media used to visualize coronary veins, Rise in threshold and exit block, Thrombolytic or air embolism, Valve damage Performance of a coronary sinus venogram is unique to lead placement in the cardiac venous system, and carries risks. Potential complications reported with direct subclavian venipuncture include hemothorax, laceration of the subclavian artery, arteriovenous fistula, neural damage, thoracic duct injury, cannulation of other vessels, massive hemorrhage, and rarely, death.