This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Medtronic AT500TM DDDRP Pacing System including Model 9968 Software
Manufacturer: Medtronic Inc.
Address: 710 Medtronic Parkway NE, Minneapolis, MN 55432
Approval Date: March 27, 2003
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/P980035s013a.pdf
What is it? The Medtronic AT500 DDDRP pacing system is an implanted, two-chambered pacemaker that responds to the need for changes in heart rate. It is for patients with a slow heart rate (bradycardia), as well for those having excessively fast or other unstable heart rates in the upper chambers of the heart (the atria). The pacing system relieves the symptoms of an abnormal heart rhythm by restoring a normal one.
How does it work? The pacing system consists of a pulse generator (battery and electronic circuitry) and leads (insulated wires) that carry electronic impulses between the generator and the heart. Because it is dual-chambered, the system can deliver stimuli to both the upper (atrial) and lower (ventricular) heart chambers. The pacing system delivers electrical pulses in an attempt to restore a normal heart rhythm when the heart is beating too fast or too slowly.
By means of a hand-held device that communicates with the pacemaker called the telemetry activator, the patient can verify if the pacemaker detected a suspected abnormal atrial rhythm, and determine if the abnormal rhythm was recorded in the device memory.
For a drawing of the heart please go to: http://www.nlm.nih.gov/medlineplus/ency/imagepages/1056.htm
When is it used? The Pacing System is used in patients who have an indication of a slow heart beat (bradycardia) and who have, or may be at risk for, excessively fast beating of the upper heart chambers (atrial tachyarrhythmias). It is also indicated for patients with other heart rhythm abnormalities.
What will it accomplish? This Pacing System may relieve some symptoms of slow heartbeat such as dizziness, extreme fatigue, shortness of breath or fainting spells. It may also restore a normal heart rhythm when the heart is beating too fast.
When should it not be used? The Medtronic AT500 DDDRP pacing system should not be used:
- for implantation with leads with a single electrode in the heart,
- for implantation along with another device for slow heartbeat, or
- for implantation with an implantable cardioverter defibrillator (ICD).
Additional Information: Summary of Safety and Effectiveness and labeling is available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=P980035s013