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Syncra™ CRT-P

Cardiac Resynchronization Therapy Pacemaker

Indications, Safety, and Warnings

The Consulta CRT-P and Syncra CRT-P systems are indicated for the following:

The Consulta CRT-P and Syncra CRT-P systems are indicated for NYHA Functional Class III or IV patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction of ≤ 35% and a prolonged QRS duration.

Rate adaptive pacing is provided for those patients developing a bradycardia indication who might benefit from increased pacing rates concurrent with increases in activity.

Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.

Atrial rhythm management features such as Atrial Rate Stabilization (ARS) (Consulta CRT-P only) and Post Mode Switch Overdrive Pacing (PMOP) are indicated for the suppression of atrial tachyarrhythmias in patients with atrial septal lead placement and one or more of the above pacing indications.

The Consulta CRT-P system also includes antitachycardia pacing (ATP), indicated for termination of atrial tachyarrhythmias in patients with one or more of the above pacing indications.

Contraindications

The Consulta CRT-P and Syncra CRT-P systems are contraindicated for:

  • Concomitant implant with another bradycardia device
  • Concomitant implant with an implantable cardioverter defibrillator

There are no known contraindications for the use of pacing as a therapeutic modality to control heart rate. The patient’s age and medical condition, however, may dictate the particular pacing system, mode of operation, and implant procedure used by the physician.

  • Rate-responsive modes may be contraindicated in those patients who cannot tolerate pacing rates above the programmed Lower Rate.
  • Dual chamber sequential pacing is contraindicated in patients with chronic or persistent supraventricular tachycardias, including atrial fibrillation or flutter.
  • Asynchronous pacing is contraindicated in the presence (or likelihood) of competition between paced and intrinsic rhythms.
  • Single chamber atrial pacing is contraindicated in patients with an AV conduction disturbance.
  • ATP therapy is contraindicated in patients with an accessory antegrade pathway (for Consulta CRT-P only)


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.
  • Certain programming and device operations may not provide cardiac resynchronization.


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 manual 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 and/or consult Medtronic’s website at www.medtronic.com.

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