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® SelectSecure™ Lead Model 3830
Applicant: Medtronic, Inc.
Address: 7000 Central Avenue NE, Minneapolis, MN 55432-3576
Approval Date: August 3, 2005
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/p030036a.pdf
What is it and when is it used? The Medtronic® SelectSecure™ Lead Model 3830 is a surgically implanted wire that connects the heart to an implanted pacemaker. A pacemaker is a small, battery-operated electronic device which is inserted under the skin to help the heart beat regularly and at an appropriate rate. The SelectSecure™ Lead Model 3830 allows a pacemaker to monitor and pace the heart and slowly releases a steroid (beclomethasone dipropionate) into the body.
The Medtronic® SelectSecure™ Lead Model 3830 is used when implantable atrial or ventricular, single-chamber or dual-chamber pacing systems are indicated. The Model 3830 lead is intended for pacing and sensing in the atrium or ventricle.
How does it work?
- The lead is inserted through a large vein connected to the heart. The lead has a helix (screw) that is inserted into the atrium or ventricle of the heart.
- The steroid beclomethasone dipropionate is released into the body from the tip of the lead for a short time after implantation, to help the tissue around the lead to conduct electricity more easily.
- Once the lead is placed in the heart and connected to an implanted pacemaker, the lead detects and transmits electrical signals from the heart to the attached pacemaker.
- The pacemaker then sends electrical signals through the lead to the heart at a specific rate.
- The heart responds to the electrical signals by beating at the same rate.
What will it accomplish? The SelectSecure ™ Lead Model 3830, in conjunction with an implanted pacemaker, treats irregular or slow heart rhythm (bradycardia). If bradycardia is not treated, it can lead to fatigue, shortness of breath, dizziness, or fainting.
When should it not be used? The SelectSecure ™ Lead Model 3830 should not be used:
- in the ventricle, in patients with tricuspid valvular disease
- in the ventricle, in patients with mechanical tricuspid heart valves
- in patients who are contraindicated for a single dose of 40 µg of beclomethasone dipropionate
- in patients with obstructed or inadequate vasculature for intravenous catheterization.
Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p030036