Indications, contraindications, warnings, precautions, and adverse events

Medtronic Implantable Cardioverter Defibrillator Systems Disclosure

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 patient’s disease and/or medications may alter the efficacy of the device’s programmed parameters.
• Patients should stay away from sources of magnetic and electromagnetic radiation, including MRI, diathermy, and electrosurgical units, to avoid possible underdetection, inappropriate therapy delivery, and/or electrical reset of the device.
• Do not place transthoracic defibrillation paddles directly over the device.

Potential Complications

Medtronic implantable cardioverter defibrillator systems include, but are not limited to, failure to detect and/or terminate tachyarrhythmia episodes, acceleration of ventricular tachycardia, and lead system complications.

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.

GEM^® III AT Disclosure

Indications for Use:

The Medtronic GEM^® III AT system is indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias. The implantable cardioverter-defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. In addition, the GEM^® III AT system is also intended to provide pacing, cardioversion, and defibrillation for treatment of patients with symptomatic, drug-refractory, atrial fibrillation, and/or life-threatening ventricular tachyarrhythmias.

Contraindications:

Do not use the GEM III AT system in patients whose tachyarrhythmias may have transient or reversible causes; patients with incessant ventricular tachyarrhythmias; patients with chronic atrial tachyarrhythmias and no concomitant ventricular tachyarrhythmias; patients who have a unipolar pacemaker; or patients whose primary disorder is bradyarrhythmias.

Warnings/Precautions:

Changes in the patient’s disease and/or medications may alter the efficacy of the device’s programmed parameters.

• Patients should stay away from sources of magnetic and electromagnetic radiation, including MRI, diathermy, and electrosurgical units, to avoid possible underdetection, inappropriate therapy delivery, and/or electrical reset of the device.
• Do not place transthoracic defibrillation paddles directly over the device.
• Use of the ICD system should not change the application of established anticoagulation protocols.
• Following an ischemic or cerebrovascular accident, disable atrial defibrillation therapies until the patient has stabilized.

Potential Complications include, but are not limited to, failure to detect and/or terminate tachyarrhythmia episodes, acceleration of tachyarrhythmia episodes, and lead system complications.

See the appropriate technical manual for detailed information regarding instructions for use, indications, contraindications, warnings, precautions, and potential complications or adverse events.

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

Disclosure 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 or properly licensed practitioner.

Medtronic CareLink^® Programmer - Disclosure

Medtronic CareLink^® Programmer (Model 2090) and Model 9790 Programmer Disclosure

The Medtronic CareLink^® Programmer system and Medtronic/Vitatron 9790 Programmer system are comprised of prescription devices indicated for use in the interrogation and programming of implantable medical devices. Prior to use, refer to the Programmer Reference Guide as well as the appropriate programmer software and implantable device technical manuals for more information related to specific implantable device models. Programming should be attempted only by appropriately trained personnel after careful study of the technical manual for the implantable device and after careful determination of appropriate parameter values based on the patient's condition and pacing system used. The Medtronic CareLink Programmer and 9790 Programmer must be used only for programming implantable devices manufactured by Medtronic or Vitatron.

Medtronic CareLink^® Monitor Disclosure

The Medtronic CareLink^® Monitor is a prescription device indicated for use in the transfer of patient data from some Medtronic implantable cardiac devices based on physician instructions and as described in the product manual. This product is not a substitute for appropriate medical attention in the event of an emergency and should only be used as directed by a physician.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician (or properly licensed practitioner). Refer to the technical manual for complete directions for use and full disclosure.

The following Medtronic ICDs are currently available for use in the continental US, Alaska and Hawaii.

See specific devices to review indications, contraindications, warnings and precautions. CRT ICD devices now connected to the Network include: Maximo™ DR ICD, Maximo™ VR ICD, InSync II Marquis™ , InSync Marquis™, InSync ICD^®. The following Medtronic ICDs are also currently available for use with the Medtronic CareLink Network: Marquis^® DR/VR, GEM® III DR/VR, GEM^® II DR/VR, GEM^® DR, GEM^®.

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