📋 FDA Reference
Lifeline Pacing Lead Model 465-01
Intermedics
Summary: The Lifeline Pacing Lead Model 465-01 is a cardiac pacing lead used in pacemaker systems to manage heart rhythm disorders. It is primarily used by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K781497 ↗
Decision Date ?
February 1, 1979
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Lifeline Pacing Lead Model 465-01 was cleared through the FDA 510(k) pathway on February 1, 1979, by Intermedics. It is classified as a Class III medical device under product code DTB.
What It Is
The Lifeline Pacing Lead Model 465-01 is a specialized wire that connects a pacemaker to the heart muscle, enabling electrical impulses to regulate heartbeats. It is designed to be implanted within the heart's chambers, ensuring reliable cardiac pacing. The lead is a critical component in pacemaker systems, providing the necessary interface for electrical conduction.
FDA-Cleared Indications
- Use as a component of a cardiac pacemaker system to deliver electrical stimulation to the heart.
- Cardiac pacing for patients with bradycardia or impaired cardiac conduction, including heart block, when pacing is clinically indicated.
Clinical Applications
- Implantation as part of a permanent pacemaker system.
- Connection of a pacemaker generator to the appropriate chamber of the heart.
- Long-term cardiac pacing in patients with clinically significant slow heart rates or conduction abnormalities.
- Monitoring lead performance during follow-up of an implanted pacemaker system.
Practical Considerations
- The lead must be matched to a compatible pacemaker generator and implanted using the specifications in the applicable labeling and physician instructions.
- Placement requires fluoroscopic or other appropriate imaging guidance, electrical testing, and confirmation of stable lead position.
- Patients require follow-up testing to assess sensing, pacing thresholds, lead integrity, and battery or generator status.
- MRI safety cannot be assumed from the device name alone. This is an older lead, and MRI eligibility depends on the complete implanted system and current manufacturer and institutional guidance.
- Potential complications include lead dislodgement, failure to capture or sense, insulation or conductor damage, infection, thrombosis, perforation, and arrhythmia.
Frequently Asked Questions
What is Lifeline Pacing Lead Model 465-01 used for?
It is used for cardiac pacing in patients with heart rhythm disorders, such as bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device.
What are the FDA-cleared indications?
It is indicated for patients needing 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.