📋 FDA Reference
Lifeline Pacing Lead Model 467-01
Intermedics
Summary: The Lifeline Pacing Lead Model 467-01 is a cardiac pacing lead used in conjunction with pacemakers to manage arrhythmias. It is primarily used by cardiologists in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K781499 ↗
Decision Date ?
February 1, 1979
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Lifeline Pacing Lead Model 467-01 was cleared through the FDA 510k pathway on February 1, 1979. It is manufactured by Intermedics and classified as a Class III medical device.
What It Is
The Lifeline Pacing Lead Model 467-01 is a medical device used to deliver electrical impulses from a pacemaker to the heart muscle, ensuring proper heart rhythm. It is designed to be implanted into the heart and connected to a pacemaker device. This lead is crucial in managing patients with bradycardia or other arrhythmias, providing consistent pacing to maintain adequate heart rates.
FDA-Cleared Indications
- Use with a permanent pacemaker system for cardiac pacing in patients with clinically indicated bradycardia or conduction disorders.
- Placement in the heart to deliver pacing stimuli from an implanted pulse generator to the cardiac muscle.
Clinical Applications
- Permanent pacemaker implantation for patients with symptomatic bradycardia.
- Pacing support for conduction disorders such as heart block when a pacemaker is indicated.
- Pacing in selected patients with sick sinus syndrome when permanent pacing is clinically indicated.
- Connection of an implanted pacemaker pulse generator to the heart during a cardiac pacing procedure.
Practical Considerations
- The lead must be compatible with the selected pacemaker pulse generator and the complete pacing system.
- Correct intracardiac placement, electrical testing, and secure fixation are important for reliable sensing and pacing.
- Available lead length and configuration should be matched to the patient's anatomy and the intended implantation approach.
- MRI safety cannot be assumed for this older lead model; the complete implanted system should be evaluated against current manufacturer and MRI labeling before scanning.
- Potential contraindications and complications include infection, bleeding, venous injury, lead displacement, perforation, pneumothorax, and loss of adequate sensing or capture.
Frequently Asked Questions
What is Lifeline Pacing Lead Model 467-01 used for?
It is used to deliver electrical impulses from a pacemaker to the heart to manage arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac procedures.
What are the FDA-cleared indications?
It is indicated for patients requiring cardiac pacing due to arrhythmias such as 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.