📋 FDA Reference
Lifeline Endocardial Pacing Lead 479-05
Intermedics
Summary: The Lifeline Endocardial Pacing Lead 479-05 is a cardiac pacing lead used in pacemaker systems to maintain heart rhythm. It is used by cardiologists and electrophysiologists in patients requiring cardiac pacing.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K830782 ↗
Decision Date ?
April 18, 1983
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Lifeline Endocardial Pacing Lead 479-05 was cleared through the FDA 510(k) pathway on April 18, 1983. It is manufactured by Intermedics and classified as a Class III medical device.
What It Is
The Lifeline Endocardial Pacing Lead 479-05 is a component of a cardiac pacing system, designed to deliver electrical impulses from a pacemaker to the heart muscle. It is an endocardial lead, meaning it is placed inside the heart via the venous system. The lead is crucial for ensuring proper electrical conduction and maintaining an adequate heart rate in patients with arrhythmias or heart block.
FDA-Cleared Indications
- Use as an endocardial lead in a cardiac pacemaker system when cardiac pacing is indicated.
- Use to deliver electrical stimulation to the heart in patients requiring pacing for symptomatic slow heart rhythms or conduction disorders.
Clinical Applications
- Implantation as the endocardial lead component of a permanent pacemaker system.
- Delivery of pacing impulses from a compatible pacemaker generator to the endocardial surface of the heart.
- Cardiac pacing in patients with bradycardia or heart block when a pacemaker is clinically indicated.
Practical Considerations
- The lead must be compatible with the selected pacemaker generator, including connector configuration and electrical specifications.
- Placement requires venous access and fluoroscopic or other appropriate imaging guidance, followed by testing of sensing, pacing thresholds and lead stability.
- Lead size and length must be selected for the patient's venous anatomy and intended intracardiac position.
- The record provided does not establish MRI compatibility; MRI should not be performed unless the complete implanted system is specifically labeled as MRI-conditional.
- Potential complications include lead dislodgement, failure to capture or sense, venous thrombosis, cardiac perforation, arrhythmia and infection.
Frequently Asked Questions
What is Lifeline Endocardial Pacing Lead 479-05 used for?
It is used to deliver electrical impulses from a pacemaker to the heart to maintain a regular heart rhythm in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in the context of pacemaker implantation procedures.
What are the FDA-cleared indications?
The device is indicated for patients who require cardiac pacing due to conditions like bradycardia or heart block.
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.