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medtronic models 4057m 4058m 4557m pacing leads
Medtronic Vascular
Summary: Medtronic models 4057m, 4058m, and 4557m are pacing leads used in cardiac pacing systems. They are utilized by cardiologists to manage arrhythmias in patients requiring pacemaker implantation.
FDA Clearance Information
Pathway
510K
Number
K932172 ↗
Decision Date
December 8, 1993
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
These Medtronic pacing leads were cleared through the FDA 510(k) pathway on December 8, 1993. Manufactured by Medtronic Vascular, they are classified as Class III medical devices.
What It Is
The Medtronic models 4057m, 4058m, and 4557m are pacing leads designed for use in cardiac pacing systems. These leads are integral components that deliver electrical impulses from the pacemaker to the heart muscle, ensuring proper heart rhythm. They are typically implanted transvenously and are compatible with a variety of pacemaker generators.
Clinical Applications
Pacing leads are commonly used in the management of bradyarrhythmias, where the heart beats too slowly. Cardiologists and electrophysiologists implant these leads during pacemaker insertion procedures, often performed in hospital catheterization labs. Patients benefiting from these devices include those with sick sinus syndrome, heart block, or other conduction disorders.
Indications for Use
These pacing leads are indicated for patients requiring cardiac pacing due to conditions like bradycardia or heart block. They help maintain adequate heart rate and rhythm in patients with impaired cardiac conduction.
Practical Considerations
Medtronic pacing leads come in various lengths and configurations to accommodate different patient anatomies and pacing needs. They are designed for compatibility with Medtronic pacemaker generators and require careful handling during implantation to ensure proper positioning and function.
Frequently Asked Questions
What is Medtronic pacing leads used for?
They are used in cardiac pacing systems to manage arrhythmias by delivering electrical impulses to the heart.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use these devices in cardiac pacing procedures.
What are the FDA-cleared indications?
These leads are indicated for patients needing cardiac pacing due to 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.