📋 FDA Reference
Model 486-02 Endocardial Pacing Lead
Intermedics
Summary: The Model 486-02 Endocardial Pacing Lead is a cardiac device used to deliver electrical impulses to the heart muscle, ensuring proper heart rhythm. It is primarily used by cardiologists in patients requiring pacing therapy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K860547 ↗
Decision Date ?
June 13, 1986
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Model 486-02 Endocardial Pacing Lead was cleared through the FDA 510(k) pathway on June 13, 1986. Manufactured by Intermedics, it is classified as a Class III device under product code DTB.
What It Is
The Model 486-02 Endocardial Pacing Lead is a specialized wire designed to be placed inside the heart's chambers to deliver electrical impulses from a pacemaker to the heart muscle. This device helps maintain an appropriate heart rate in patients with arrhythmias. It is typically inserted via a transvenous approach and positioned in the right atrium or ventricle.
FDA-Cleared Indications
- Cardiac pacing in patients with symptomatic bradycardia.
- Cardiac pacing for atrioventricular block and other clinically significant conduction disorders.
- Transvenous placement in a cardiac chamber to deliver pacing stimuli from an implanted pacemaker.
Clinical Applications
- Placement in the right atrium when atrial pacing is clinically indicated.
- Placement in the right ventricle when ventricular pacing is clinically indicated.
- Use as part of an implanted pacemaker system for chronic management of bradycardia or conduction disease.
- Use during a transvenous pacemaker implantation or lead-revision procedure.
Practical Considerations
- The lead is placed through a venous access site and advanced under fluoroscopic guidance into the selected right-sided heart chamber.
- The appropriate lead length and configuration depend on patient anatomy, the intended chamber, and the pulse generator system.
- Compatibility must be confirmed with the pacemaker generator and any connectors; the original device labeling and manufacturer information should guide system selection.
- MRI safety cannot be assumed for this older lead. MRI eligibility depends on the complete implanted system and should be confirmed before scanning.
- Potential complications include lead displacement, failure to capture or sense, venous injury, arrhythmia, infection, thrombosis, and cardiac perforation. Contraindications and precautions depend on the patient's condition and the complete pacing system.
Frequently Asked Questions
What is the Model 486-02 Endocardial Pacing Lead used for?
It is used to deliver electrical impulses to the heart to maintain a proper heart rhythm in patients with arrhythmias.
What specialties typically use this device?
Cardiologists, especially those specializing in electrophysiology, use this device in clinical practice.
What are the FDA-cleared indications?
The device is indicated for patients with symptomatic bradycardia, atrioventricular block, or other conduction disorders requiring pacing.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.