Disclosure | Medtronic Cardiology

Heart Failure

Indications, contraindications, warnings, precautions and adverse events

Brief Statement for Medtronic CRT and CRT-ICD Systems and Attain Leads

CRT: InSync 8040 Generator, InSync III 8042 Generator

CRT-ICD: InSync ICD 7272, InSync Marquis 7277, InSync II Marquis 7289, InSync II Protect 7295, InSync Maximo 7303/7304, InSync Sentry 7297/7299

Attain Leads: Models 2187, 2188, 4193, and 4194 Leads

Indications

Medtronic CRT and CRT-ICD devices are 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 ≤35% and a prolonged QRS duration.
The InSync III Model 8042 is also intended to provide rate adaptive pacing for patients who may benefit from increased pacing rates concurrent with increases in activity. Rate adaptive pacing is intended only for those patients developing a bradycardia indication who might benefit from increased pacing rates concurrent with increases in activity. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.
Medtronic CRT-ICD devices are also indicated for ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.
The Attain Leads have application as part of a Medtronic biventricular pacing system.

Contraindications

Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
CRT-ICD Devices are contraindicated for patients whose ventricular tachyarrhythmias may have transient or reversible causes and for patients with incessant VT or VF.
CRT Devices are contraindicated for Dual chamber atrial pacing in patients with chronic refractory atrial tachyarrhythmias.

Attain Leads:

Are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
For the Model 4193 and 4194 leads, do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

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.
Leads, stylets, and guidewires should be handled with great care at all times. When using a Model 4193 or 4194 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).

Potential Complications

Potential device 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.

Attain leads:

Potential complications related to the use of endocardial leads include, but are not limited to, cardiac perforation, cardiac tamponade, embolism, exit block, fibrillation and other arrhythmias, heart wall rupture, infection, muscle or nerve stimulation, myocardial irritability, pneumothorax, thrombosis, tissue necrosis, valve damage, lead dislodgement, lead fracture, insulation failure, threshold elevation, and poor connection to the device, which may lead to oversensing, undersensing, or a loss of therapy.

See the 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.