Disclosure for 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.

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