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model 841 endocardial tined lead
Pacesetter Systems
Summary: The Model 841 Endocardial Tined Lead is a cardiac pacing lead used in pacemaker systems to maintain heart rhythm. It is primarily used by cardiologists in patients with arrhythmias.
FDA Clearance Information
Pathway
510K
Number
K812816 ↗
Decision Date
October 29, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model 841 Endocardial Tined Lead was cleared through the FDA 510(k) pathway on October 29, 1981. Manufactured by Pacesetter Systems, it is classified as a Class III device.
What It Is
The Model 841 Endocardial Tined Lead is a specialized wire used in cardiac pacemaker systems. It is designed to be implanted inside the heart, where its tined structure helps secure it in place within the endocardium. The lead transmits electrical impulses from the pacemaker to the heart, ensuring proper heart rhythm in patients with arrhythmias.
Clinical Applications
This device is commonly used in cardiac electrophysiology and cardiology settings, particularly for patients requiring long-term pacing due to conditions like bradycardia or heart block. It is typically used in hospitals or specialized cardiac centers, and is suitable for adult and pediatric patients who require an implantable pacing system.
Indications for Use
The Model 841 Endocardial Tined Lead is indicated for use in patients who need cardiac pacing to manage arrhythmias. This includes individuals with slow heart rates or irregular heartbeats that require stabilization through electrical pacing.
Practical Considerations
Clinicians should consider the lead's compatibility with the chosen pacemaker system. Proper placement technique is crucial to ensure stability and function, and the tined design aids in securing the lead within the heart tissue. Sizing may vary depending on patient anatomy.
Frequently Asked Questions
What is the Model 841 Endocardial Tined Lead used for?
It is used for cardiac pacing in patients with arrhythmias to maintain proper heart rhythm.
What specialties typically use this device?
Cardiologists and cardiac electrophysiologists typically use this device in clinical practice.
What are the FDA-cleared indications?
It is indicated for patients requiring cardiac pacing due to arrhythmias such as 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.