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medtronic model 5058 bipolar implantable screw-in ventricular atrial transvenous lead
Medtronic Vascular
Summary: The Medtronic Model 5058 is a bipolar implantable screw-in lead used in cardiac pacing. It's primarily used by cardiologists for patients requiring ventricular or atrial pacing.
FDA Clearance Information
Pathway
510K
Number
K962036 ↗
Decision Date
August 22, 1996
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Medtronic Model 5058 was cleared through the FDA 510(k) pathway on August 22, 1996. Manufactured by Medtronic Vascular, it is classified as a Class III device.
What It Is
The Medtronic Model 5058 is a bipolar implantable screw-in lead designed for transvenous placement in the heart. It facilitates electrical pacing by delivering impulses to either the atrium or ventricle. The screw-in mechanism ensures stable fixation within the cardiac tissue, enhancing pacing reliability.
Clinical Applications
This lead is commonly used in cardiac pacing procedures, particularly in patients with bradycardia or heart block. It is utilized in both atrial and ventricular pacing, making it versatile for various cardiac rhythm management scenarios. Cardiologists and electrophysiologists typically implant these leads in hospital settings, often during pacemaker insertion surgeries.
Indications for Use
The device is indicated for patients requiring electrical pacing support due to conditions like atrioventricular block or sinus node dysfunction. It helps maintain adequate heart rates in patients with these conditions.
Practical Considerations
The lead is available in various lengths to accommodate different patient anatomies. It is compatible with a range of pacemaker devices, and the screw-in design requires precise placement technique to ensure optimal performance and longevity.
Frequently Asked Questions
What is the Medtronic Model 5058 Lead used for?
It is used for cardiac pacing in patients with conditions like bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac pacing procedures.
What are the FDA-cleared indications?
It is indicated for patients needing ventricular or atrial pacing due to heart rhythm disorders like AV block or sinus node dysfunction.
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.