Other Medtronic ICD Defibrillators
 

Indications, Safety, and Warnings

Medtronic ICD Defibrillator Systems

Indications/Contraindications

Medtronic implantable cardioverter defibrillator (ICD) systems are indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Contraindicated for patients with transient or reversible ventricular tachyarrhythmia or as the sole treatment of atrial arrhythmia.

Warnings/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.

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.

See the technical manual for detailed uses, contraindications, warnings, precautions, and potential complications.

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


Medtronic Leads

Indications

Medtronic leads are designed for use with a compatible IPG or an ICD as part of a cardiac system. Leads are intended for delivering therapies and/or sensing in the atrium and/or ventricle of the heart.

Contraindications

Use of ventricular transvenous leads is contraindicated in patients with tricuspid valvular disease and/or patients with mechanical tricuspid heart valves.

Use of steroid-eluting leads is contraindicated in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate or dexamethasone acetate may be contraindicated.

Warnings/Precautions

People with metal implants such as pacemakers, implantable cardioverter defibrillators, and accompanying leads should not receive diathermy treatment.

Potential Complications

Valve damage, fibrillation and other arrhythmias, thrombolytic and air embolism, cardiac perforation, heart wall rupture, cardiac tamponade, muscle or nerve stimulation, pericardial rub, infection, myocardial irritability, thrombosis and pneumothorax. Other potential complications related to the lead may include lead dislodgement, lead conductor fracture or insulation failure or threshold elevation or exit block.

Additional potential patient related complications related to the use of subcutaneous leads include but are not limited to the following conditions: bleeding, blood vessel damage, chest wall perforation, muscle tissue damage, pain, puncture of abdominal organs, spinal column, or thoracic organs, serous fluid accumulation around lead electrode or lead body, and skin perforation.

See the specific lead technical manual for detailed uses, contraindications, warnings, precautions and potential complications.

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

Last updated: 22 Sep 2010