Medtronic
 
 

Tachyarrhythmia
Management

Brief Statement

Concerto Model C154DWK and Virtuoso Models D154AWG/D154VWC (DR/VR)

Indications for Concerto: Concerto is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The system is also indicated for the 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, and have a left ventricular ejection fraction = to 35% and a prolonged QRS duration.

Indications for Virtuoso: Virtuoso DR/VR devices are indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias in patients with NYHA functional class II/III heart failure. The Virtuoso DR device is also indicated for use in the above patients with atrial tachyarrhythmias, or those patients who are at significant risk of developing atrial tachyarrhythmias. Atrial rhythm management features, available on the Virtuoso DR, such as Atrial Rate Stabilization (ARS), Atrial Preference Pacing (APP), and Post Mode Switch Overdrive Pacing (PMOP) are indicated for the suppression of atrial tachyarrhythmias in ICD-indicated patients with atrial septal lead placement and an ICD indication. Due to the addition of the OptiVol diagnostic feature, the Virtuoso indication is limited to NYHA functional class II/III heart failure patients who are indicated for an ICD. The clinical value of the OptiVol fluid monitoring diagnostic feature has not been assessed in those patients who do not have fluid retention related symptoms due to heart failure.

Contraindications for Concerto: Concerto is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes; patients with incessant VT or VF; and patients who have a unipolar pacemaker.

Contraindications for Virtuoso: Virtuoso DR/VR devices are contraindicated for patients experiencing any of the following conditions: tachyarrhythmias with transient or reversible causes, incessant ventricular tachycardia or ventricular fibrillation, present implant of a unipolar implantable pulse generator, and primary disorder or bradyarrhythmia. Virtuoso DR is also contraindicated for patients who have a primary disorder of chronic atrial tachyarrhythmia with no concomitant VT or VF. Additionally, Virtuoso VR is contraindicated for patients who have a primary disorder of atrial arrhythmia.

Warnings and Precautions: Changes in a patient's disease and/or medications may alter the efficacy of the device's programmed parameters. Patients should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection, inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia, device electrical reset or device damage. Do not place transthoracic defibrillation paddles directly over the device. Certain programming and device operations may not provide cardiac resynchronization.

Potential Complications: Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve stimulation, oversensing, failure to detect and/or terminate tachyarrhythmia episodes, acceleration of ventricular tachycardia, and surgical complications such as hematoma, infection, inflammation, and thrombosis.

Model 27901 Conexus Activator

Intended Use: The Conexus Activator is intended for use by clinicians to enable Conexus wireless telemetry in a Conexus compatible heart device. After Conexus telemetry has been enabled, a session can be conducted with a CareLink programmer without the use of a programming head. The Conexus Activator determines if a Medtronic heart device is Conexus compatible and enables Conexus wireless telemetry in the Medtronic heart device. Contraindications: There are no known contraindications for the Conexus Activator.

Model 2090 CareLink Programmer

The Medtronic CareLink programmer is a portable, microprocessor-based instrument used to program Medtronic implantable devices.

See device manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic's website at www.medtronic.com .

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

 

 

Additional Information