CD2357-40Q, St. Jude Medical, Implantable Cardioverter Defibrillator, Fortify Assura DR 40, Dual-chamber ICD with RF telemetry, Connector DF4-LLHH/IS-1

Indications and Usage

St. Jude Medical™ ICDs and CRT-Ds are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
AF Suppression™ pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction.
In patients indicated for an ICD, CRT-Ds are also intended:

•  to provide a reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section included in the Merlin PCS on-screen help) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration
•  to maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III heart failure

  The pulse generator, along with compatible, commercially available leads, constitutes the implantable portion of the ICD and CRT-D systems. The lead systems are implanted using either transvenous or transthoracic techniques. The St. Jude Medical Merlin™ Patient Care System (PCS) with software model 3330 version 24.0.1 (or greater), a Merlin™ Antenna (for devices with RF communication), and a telemetry wand constitute the external portion of the ICD and CRT-D systems.

Models with the “Q” suffix are functionally equivalent in all respects to the same model without the “Q” suffix, except for the header. Models without the "Q” suffix use DF-1 lead connectors for the high-voltage leads, and models with the "Q” suffix use a single DF4-LLHH lead connector for the high-voltage leads and for the low voltage RV lead.

SJ4-LLHH is equivalent to DF4-LLHH. SJ4 and DF4 connectors comply with ISO 27186:2010(E).SJ4-LLLL is equivalent to IS4-LLLL. SJ4 and IS4 connectors comply with ISO 27186:2010(E).