📋 FDA Reference
Pacesetter Systems Endocardial Small Fin Lead
Pacesetter Systems
Summary: The Pacesetter Systems Endocardial Small Fin Lead is a cardiac pacing lead used in pacemaker implantation procedures. It is primarily utilized by cardiologists and electrophysiologists to manage patients with arrhythmias.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K854405 ↗
Decision Date ?
December 4, 1985
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Pacesetter Systems Endocardial Small Fin Lead was cleared through the FDA 510(k) pathway on December 4, 1985. Manufactured by Pacesetter Systems, this device is classified as a Class III medical device.
What It Is
The Pacesetter Systems Endocardial Small Fin Lead is a specialized cardiac lead designed for use in pacemaker systems. It is inserted into the heart's endocardial surface to deliver electrical impulses that regulate heartbeats. The 'small fin' design aids in stable placement and reduces the risk of lead dislodgement, ensuring reliable pacing performance.
FDA-Cleared Indications
- Use as an endocardial lead in a cardiac pacemaker system when cardiac pacing is indicated.
- Provide electrical stimulation to the heart in patients requiring treatment for inadequate or interrupted heart-rate conduction.
Clinical Applications
- Endocardial lead placement during implantation of a permanent pacemaker.
- Cardiac pacing for patients with clinically significant bradycardia.
- Cardiac pacing for patients with heart block or impaired electrical conduction.
- Long-term pacing support when the patient's intrinsic cardiac rhythm is inadequate.
Practical Considerations
- The small-fin design is intended to help stabilize the lead after placement; correct positioning and testing are required during implantation.
- Confirm connector, electrical, and dimensional compatibility with the selected pacemaker generator and other system components.
- The available lead sizes and specifications should be verified in the original labeling and device documentation before use.
- MRI safety should not be assumed. MRI eligibility depends on the complete implanted system and its labeling; older pacing leads may not be labeled as MRI-conditional.
- Potential complications include lead dislodgement, failure to capture or sense, venous or cardiac perforation, infection, thrombosis, and the need for revision or replacement.
Frequently Asked Questions
What is Pacesetter Systems Endocardial Small Fin Lead used for?
It is used for delivering electrical impulses to the heart in patients requiring pacemaker support due to arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in the management of cardiac arrhythmias.
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.