Brief Statement:

Medtronic EnRhythm Implantable Pulse Generator (IPG) Model P1501DR

Indications

The device is indicated for the following:

• Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity
• Accepted patient conditions warranting chronic cardiac pacing include:
  • Symptomatic paroxysmal or permanent second- or third-degree AV block
  • Symptomatic bilateral bundle branch block
  • Symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders
  • Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias

The device is 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 to cardiac output
• VVI intolerance (for example, pacemaker syndrome) in the presence of persistent sinus rhythm

Antitachycardia pacing (ATP) is indicated for termination of atrial tachyarrhythmias in bradycardia patients with one or more of the above pacing indications.

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

Contraindications

The device is contraindicated for:

• Implantation with unipolar pacing leads
• Concomitant implantation with another bradycardia device
• Concomitant implantation 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 implantation 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.
• Single chamber atrial pacing is contraindicated in patients with an AV conduction disturbance.
• ATP therapy is contraindicated in patients with an accessory antegrade pathway.

Warnings/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. Use of the device should not change the application of established anti-coagulation protocols.
• Use of the device should not change the application of established anti-coagulation protocols.

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 arrhythmia episodes, acceleration of 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.

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

©Medtronic, Inc. 2008                                                   • Contact Medtronic • Privacy Statement • Terms of Use • Site Map