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models 5069 5071 myocardial pacing leads
Medtronic Vascular
Summary: The models 5069 and 5071 myocardial pacing leads by Medtronic Vascular are used for cardiac pacing. They are typically used by cardiologists in settings requiring temporary or permanent pacing.
FDA Clearance Information
Pathway
510K
Number
K902002 ↗
Decision Date
September 26, 1990
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The models 5069 and 5071 myocardial pacing leads were cleared by the FDA via the 510k pathway on September 26, 1990. Manufactured by Medtronic Vascular, these devices are classified as Class III medical devices.
What It Is
The models 5069 and 5071 are myocardial pacing leads designed to deliver electrical impulses to the heart muscle, ensuring proper cardiac rhythm. These leads are typically used in conjunction with a pacemaker device. They are inserted into the heart via a vein and secured to the heart muscle to maintain effective cardiac pacing.
Clinical Applications
These pacing leads are commonly used in cardiology for patients with bradycardia or heart block, where the heart beats too slowly. They are utilized in both temporary and permanent pacing scenarios, often in hospital settings such as cardiac care units or during cardiac surgeries. The patient population includes those with arrhythmias or post-cardiac surgery recovery.
Indications for Use
The FDA indications for these leads include use in patients requiring pacing support due to conditions like bradycardia or heart block. They are suitable for patients who need temporary or permanent pacing solutions.
Practical Considerations
These leads come in various lengths to accommodate different patient anatomies and are compatible with most pacemaker devices. Proper insertion technique is critical to ensure effective pacing and minimize complications such as lead dislodgement.
Frequently Asked Questions
What is models 5069 5071 myocardial pacing leads used for?
These leads are used for cardiac pacing in patients with conditions like bradycardia or heart block.
What specialties typically use this device?
Cardiologists and cardiac surgeons typically use these pacing leads in hospital settings.
What are the FDA-cleared indications?
The leads are indicated for use in patients requiring pacing support due to 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.