đź“‹ 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
510K
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.
Clinical Applications
Pacing leads like the MDM 1060 and 1090 are commonly used in procedures involving the implantation of pacemakers, often in patients with bradycardia or heart block. Cardiologists and electrophysiologists typically perform these procedures in hospital settings. The leads are suitable for a wide range of patients, from those with congenital heart conditions to elderly patients with acquired heart rhythm disorders.
Indications for Use
These pacing leads are indicated for use in patients requiring cardiac pacing due to conditions like bradycardia or atrioventricular block. They help maintain a regular heart rate by delivering electrical impulses to stimulate heart contractions.
Practical Considerations
When selecting pacing leads, consider the length and diameter to ensure compatibility with the patient's anatomy and the pacemaker device. Proper technique during insertion is crucial to avoid complications such as lead dislodgement or infection.
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.