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model p in-line bipolar endocardial tined lead
Cook Pacemaker
Summary: The Model P In-Line Bipolar Endocardial Tined Lead is a cardiac device used in pacemaker systems to deliver electrical impulses to the heart. It is primarily used by cardiologists and electrophysiologists in patients requiring cardiac pacing.
FDA Clearance Information
Pathway
510K
Number
K915188 ↗
Decision Date
September 11, 1992
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on September 11, 1992. Manufactured by Cook Pacemaker, it is classified as a Class III medical device.
What It Is
The Model P In-Line Bipolar Endocardial Tined Lead is a component of pacemaker systems, designed to be implanted in the heart's endocardium. It features tines that help secure the lead in place, ensuring stable electrical contact. The bipolar design allows for more precise sensing and pacing, which is crucial for effective cardiac rhythm management.
Clinical Applications
This device is commonly used in the management of bradycardia, where patients experience abnormally slow heart rates. It is typically used in hospital settings, including cardiac catheterization labs and operating rooms, by cardiologists and electrophysiologists. The lead is suitable for a wide range of patients, from those with congenital heart conditions to the elderly with acquired heart block.
Indications for Use
The FDA indications suggest that this lead is intended for patients who require pacing due to conditions like heart block or sick sinus syndrome. It is used to maintain adequate heart rates in patients whose natural pacemaker is not functioning properly.
Practical Considerations
The lead is available in various lengths to accommodate different patient anatomies and is compatible with a range of pacemaker generators. Implantation requires careful technique to ensure proper placement and function, with attention to avoiding lead dislodgement.
Frequently Asked Questions
What is the Model P In-Line Bipolar Endocardial Tined Lead used for?
It is used to deliver electrical impulses to the heart in patients requiring pacemaker therapy, particularly for those with bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in the management of cardiac rhythm disorders.
What are the FDA-cleared indications?
The device is indicated for patients needing cardiac pacing due to conditions like heart block or sick sinus syndrome.
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.