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Medtronic Indications, contraindications, warnings, precautions, and adverse events

Disclosure for Medtronic Pacing Systems

Medtronic pacemakers are indicated for rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity (Medtronic Kappa®, Sigma™ Series, and Thera® (i-series)™) and increases in activity and/or minute ventilation (Medtronic Kappa 400 Series).

Medtronic pacemakers are also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony, which include various degrees of AV block to maintain the atrial contribution of cardiac output and VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm.

The Medtronic CareLink™ Programmer and the Medtronic 9790 Programmer are intended for use by physicians to noninvasively program Medtronic implantable devices. Specific applications are determined by the software installed in the programmer at the time of its use.

9462 Cardiac Monitor
The Medtronic 9462 Remote Assistant™ Cardiac Monitor is intended for use by the patient in combination with a Medtronic implantable pacemaker with Remote Assistant capabilities.

Medtronic pacemakers are contraindicated for the following applications:

  • Dual chamber atrial pacing in patients with chronic refractory atrial tachyarrhythmias.
  • Asynchronous pacing in the presence (or likelihood) of competitive paced and intrinsic rhythms.
  • Unipolar pacing for patients with an implanted cardioverter defibrillator (ICD) because it may cause unwanted delivery or inhibition of ICD therapy.
  • Medtronic Kappa 400 Series pacemakers are contraindicated for use with epicardial leads and with abdominal implantation.

Pacemaker patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radio frequency ablation to avoid electrical reset of the device, inappropriate sensing and/or therapy.

9462 Cardiac Monitor
Operation of the Model 9462 Remote Assistant™ Cardiac Monitor near sources of electromagnetic interference such as cellular phones, computer monitors, etc., may adversely affect the performance of this device.

See the appropriate technical manual for detailed information regarding indications, contraindications, warnings, and precautions.

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

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