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Maximo II DR and VR

ICD Defibrillators

Indications, Safety, and Warnings

Maximo II DR and VR

Indications

The Maximo® II DR and VR systems are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.

Contraindications

The Maximo II DR/VR systems are contraindicated for patients experiencing tachyarrhythmias with transient or reversible causes including, but not limited to, the following: acute myocardial infarction, drug intoxication, drowning, electric shock, electrolyte imbalance, hypoxia, or sepsis. The devices are contraindicated for patients who have a unipolar pacemaker implanted. In addition, the devices are contraindicated for patients with incessant VT or VF.

The Maximo II DR/VR devices are also contraindicated for patients whose primary disorder is atrial tachyarrhythmia.

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.

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 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.

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