📋 FDA Reference
Pacing Lead Model Mvm 860 Mvm 890
R.E. Brown
Summary: The pacing lead models MVM 860 and MVM 890 by R.E. Brown are medical devices used in cardiac pacing procedures. These leads are typically utilized by cardiologists to manage arrhythmias in patients requiring pacemaker implantation.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K781625 ↗
Decision Date ?
December 8, 1978
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The pacing lead models MVM 860 and MVM 890 were cleared through the FDA 510(k) pathway on December 8, 1978, by the manufacturer R.E. Brown. This device is classified as Class 3 under the product code DTB.
What It Is
The pacing lead models MVM 860 and MVM 890 are components of cardiac pacemaker systems. These leads are designed to deliver electrical impulses from the pacemaker to the heart muscle, ensuring proper heart rhythm. They are typically inserted into the heart via the venous system and are crucial for the effective management of bradycardia and other arrhythmias.
FDA-Cleared Indications
- Use with a cardiac pacemaker system when electrical pacing is required to maintain an adequate heart rate and rhythm.
- Use in patients with bradyarrhythmias, including atrioventricular block or sick sinus syndrome, when pacing is clinically indicated.
Clinical Applications
- Transvenous placement as part of a permanent pacemaker implantation.
- Delivery of pacing impulses from a pacemaker generator to the heart muscle.
- Cardiac pacing for clinically significant bradycardia or conduction-system disease when a pacemaker is indicated.
Practical Considerations
- The lead must be compatible with the selected pacemaker generator and appropriately sized for the patient's venous anatomy and intended lead position.
- Placement requires venous access and imaging or fluoroscopic guidance, with testing to confirm lead position and electrical performance.
- The record provided does not establish MRI-conditional labeling; MRI safety should be verified from the original device labeling and the complete implanted system.
- Potential lead-related complications include dislodgment, failure to capture or sense, venous injury or obstruction, infection, and cardiac perforation.
- Use, contraindications, handling, and removal should follow the original manufacturer labeling and current institutional cardiac-device protocols.
Frequently Asked Questions
What is pacing lead model MVM 860 MVM 890 used for?
These pacing leads are used in cardiac pacing procedures to manage heart rhythm disorders by delivering electrical impulses to the heart.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use these devices during pacemaker implantation procedures.
What are the FDA-cleared indications?
These leads are indicated for use in patients requiring electrical pacing to maintain heart rhythm, such as those with heart block or bradycardia.
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.