📋 FDA Reference
Model 492-02 Endocardial Pacing Lead
Intermedics
Summary: The model 492-02 endocardial pacing lead by Intermedics is a device used for cardiac pacing. It is primarily used by cardiologists to manage heart rhythm disorders in patients requiring pacemaker therapy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K860548 ↗
Decision Date ?
June 13, 1986
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The model 492-02 endocardial pacing lead was cleared through the FDA 510(k) pathway on June 13, 1986. Manufactured by Intermedics, this device is classified as a Class III medical device.
What It Is
The model 492-02 endocardial pacing lead is a medical device designed to deliver electrical impulses to the heart muscle to regulate heartbeats. It is typically used in conjunction with a pacemaker, which generates the electrical signals. The lead is inserted into the heart via a vein and positioned to ensure optimal contact with the heart tissue for effective pacing.
FDA-Cleared Indications
- Use as an endocardial lead with a compatible cardiac pacemaker system when permanent cardiac pacing is indicated.
- Placement in the heart through the venous system to deliver pacing impulses to the endocardium.
Clinical Applications
- Permanent pacemaker implantation for patients requiring endocardial cardiac pacing.
- Treatment of clinically significant bradycardia when pacemaker therapy is indicated.
- Connection of a compatible pacemaker generator to the heart for delivery of pacing impulses.
- Use in electrophysiology or cardiac operating-room procedures involving implantation of a permanent pacing system.
Practical Considerations
- The lead must be matched to a compatible pacemaker generator and pacing system; clinicians should confirm connector and electrical compatibility before implantation.
- Implantation generally requires venous access, fluoroscopic guidance, lead advancement into the heart, electrical testing, and fixation in an appropriate endocardial location.
- The available lead length, diameter, fixation mechanism, and other specifications should be confirmed in the original Intermedics labeling or device records before use.
- MRI compatibility should not be assumed. This older lead should be considered non-MRI-conditional unless the complete implanted system is specifically documented as MRI-conditional and current manufacturer and institutional requirements are met.
- Potential complications include lead dislodgement, failure to capture or sense, venous thrombosis or obstruction, perforation, infection, arrhythmia, and vascular or cardiac injury.
Frequently Asked Questions
What is the model 492-02 endocardial pacing lead used for?
It is used to deliver electrical impulses to the heart to regulate heartbeats in patients with rhythm disorders.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology, commonly use this device.
What are the FDA-cleared indications?
The device is indicated for patients needing assistance in maintaining a regular heart rhythm due to conditions like bradycardia.
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.