📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use as a transvenous atrial or ventricular pacing lead when cardiac pacing is clinically indicated.
- Use in patients requiring pacing support for bradycardia or impaired cardiac conduction, according to the labeling for the compatible pacemaker system.
Clinical Applications
- Atrial pacing during implantation of a compatible permanent pacemaker.
- Ventricular pacing during implantation of a compatible permanent pacemaker.
- Treatment of bradycardia requiring permanent electrical pacing.
- Pacing support for patients with atrioventricular conduction disorders or sinus node dysfunction when indicated for pacemaker therapy.
Practical Considerations
- The lead is available in different lengths; the selected length must match the patient's anatomy and the planned venous route.
- It requires transvenous placement under fluoroscopic or other appropriate imaging guidance, with active fixation by deployment of the distal screw in cardiac tissue.
- Compatibility with the intended pacemaker generator, connector configuration, electrical specifications, and programming system must be confirmed before implantation.
- MRI safety is configuration-dependent. Do not assume the lead is MRI-conditional; the complete implanted system must be checked against current manufacturer labeling before an MRI examination.
- Potential complications include lead dislodgement, failure to capture or sense, venous thrombosis, infection, cardiac perforation, pericardial effusion, arrhythmia, and pneumothorax related to venous access.
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.