📋 FDA Reference
Pacing Lead Models Mdm 1060 Mdm 1090
R.E. Brown
Summary: The MDM 1060 and 1090 are pacing leads used in cardiac pacing systems to deliver electrical impulses to the heart. They are primarily used by cardiologists in settings like hospitals and specialized cardiac centers.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K781620 ↗
Decision Date ?
December 8, 1978
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The pacing lead models MDM 1060 and 1090, manufactured by R.E. Brown, were cleared by the FDA under 510k K781620 on December 8, 1978. They are classified as Class III devices under product code DTB.
What It Is
These pacing leads are components of cardiac pacing systems, designed to transmit electrical impulses from a pacemaker to the heart muscle. They are typically inserted into the heart via the venous system and are crucial for maintaining adequate heart rhythm in patients with arrhythmias. The leads are made of biocompatible materials to ensure safety and longevity within the body.
FDA-Cleared Indications
- Use as a component of a cardiac pacemaker system to deliver electrical stimulation to the heart.
- Use in patients requiring pacing for bradycardia or atrioventricular conduction disorders, including heart block.
Clinical Applications
- Transvenous implantation during permanent pacemaker placement.
- Delivery of pacing impulses to the cardiac muscle in patients with clinically significant bradycardia.
- Use as part of pacing treatment for atrioventricular block or other impaired cardiac conduction.
- Connection between an implanted pacemaker generator and the heart.
Practical Considerations
- The lead model, length, diameter and connector must be compatible with the selected pacemaker generator and the patient's venous and cardiac anatomy.
- Implantation requires fluoroscopic or other appropriate imaging guidance and careful positioning to reduce the risk of dislodgement or perforation.
- Potential complications include infection, bleeding, venous thrombosis, lead fracture, insulation failure, dislodgement and loss of pacing function.
- MRI safety cannot be determined from the available record. The lead should be considered non-MRI-conditional unless current manufacturer documentation confirms MRI compatibility for the complete implanted system.
- The device is intended for use by trained cardiac electrophysiology or cardiology teams in an appropriate hospital or cardiac-care setting.
Frequently Asked Questions
What is the MDM 1060 & 1090 used for?
These pacing leads are used to deliver electrical impulses from a pacemaker to the heart, helping to maintain a regular heart rhythm in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use these devices, especially in hospital and specialized cardiac care settings.
What are the FDA-cleared indications?
These leads are indicated for use in patients requiring cardiac pacing due to conditions such as 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.