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medtronic models 5069 and 5071 myocardial pacing
Medtronic Vascular
Summary: The Medtronic Models 5069 and 5071 are myocardial pacing leads used in cardiac procedures. They are typically used by cardiologists to manage heart rhythm disorders in patients requiring temporary pacing.
FDA Clearance Information
Pathway
510K
Number
K915736 ↗
Decision Date
December 3, 1992
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Medtronic Models 5069 and 5071 were cleared through the FDA 510(k) pathway on December 3, 1992. Manufactured by Medtronic Vascular, these devices are classified as Class III medical devices.
What It Is
The Medtronic Models 5069 and 5071 are myocardial pacing leads designed for temporary cardiac pacing. These leads are inserted into the heart muscle to deliver electrical impulses that help maintain an adequate heart rate in patients with bradycardia or other rhythm disturbances. They are critical in situations where temporary pacing is needed, such as during cardiac surgery or in the management of acute heart block.
Clinical Applications
These pacing leads are commonly used in cardiology and cardiac surgery settings. They are particularly useful in managing patients with temporary heart rhythm issues, such as those undergoing cardiac surgery or experiencing acute myocardial infarction with heart block. The devices are used in hospitals, especially in intensive care units and cardiac catheterization labs, where continuous cardiac monitoring is available.
Indications for Use
The FDA-cleared indications for these devices include temporary pacing in patients with bradycardia or heart block. They are intended for use in patients who require short-term pacing support during or after cardiac procedures.
Practical Considerations
The Medtronic myocardial pacing leads are available in various lengths to accommodate different patient anatomies. They are compatible with most temporary pacemakers. Proper insertion technique is crucial to ensure effective pacing and minimize complications.
Related Literature
The linked study, 'Introducing the OUTPACE Framework for Health Care Quality Improvement,' focuses on improving healthcare quality through standardized guidelines and quality measures. It highlights the role of professional societies in developing evidence-based recommendations and the use of implementation science strategies to enhance care quality. However, the study does not directly address the Medtronic pacing leads.
Frequently Asked Questions
What is Medtronic Models 5069 and 5071 used for?
These devices are used for temporary myocardial pacing in patients with heart rhythm disorders such as bradycardia or heart block.
What specialties typically use this device?
Cardiologists and cardiac surgeons typically use these devices in hospital settings, particularly in intensive care units and during cardiac procedures.
What are the FDA-cleared indications?
The devices are indicated for temporary pacing in patients with bradycardia or heart block, especially during or after cardiac procedures.
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.