Description
Rx only
Intended Use: Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices are intended to provide ventricular antitachycardia pacing and ventricular cardioversion/defibrillation. CRT-D devices are also intended to resynchronize the right and left ventricles.
Indications: CRT-D devices are indicated for the automated treatment of life-threatening ventricular arrhythmias. CRT-D devices are also indicated for treating symptoms in patients with congestive heart failure with ventricular dyssynchrony.
In addition, CRT-D devices with the AT/AF detection algorithm are indicated for patients with atrial tachyarrhythmias or patients at significant risk of developing atrial tachyarrhythmias.
MR Conditional CRT-Ds are conditionally safe for use in the MRI environment when used in a complete MR Conditional system and according to the instructions in the MRI-Ready Systems manual. Scanning under different conditions can result in serious patient injury, death, or device failure.
Contraindications: Contraindications to the use of the pulse generator system include ventricular tachyarrhythmias caused by transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction.