📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use as a component of a cardiac pacing system in patients who require electrical pacing.
- Transvenous delivery of pacing impulses from a pacemaker generator to the heart.
Clinical Applications
- Implantation during a pacemaker procedure for patients requiring cardiac pacing.
- Treatment of bradyarrhythmias when pacing is clinically indicated.
- Pacing support for conduction disorders such as heart block, when included in an indicated pacemaker system.
Practical Considerations
- The models have different configurations and lengths; selection depends on cardiac anatomy, the intended chamber, and the compatible pacemaker generator.
- Implantation typically uses venous access and fluoroscopic imaging, with positioning and electrical measurements performed before the lead is connected to the generator.
- Compatibility with the specific pacemaker generator and connector standard must be confirmed before implantation.
- MRI eligibility cannot be determined from the lead model alone. It depends on the complete implanted system, generator, lead combination, and current labeling; older systems may not be MRI-conditional.
- Potential complications include lead dislodgement, fracture, insulation damage, infection, venous thrombosis, perforation, abnormal pacing, and the need for revision or extraction.
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.