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medtronic model 4081 4581 4582 target tip pacing l
Medtronic Vascular
Summary: The Medtronic Model 4081 4581 4582 is a pacing lead used in cardiac procedures. It is primarily used for pacing in patients with heart rhythm disorders. Key evidence includes studies on its clinical efficacy and safety.
FDA Clearance Information
Pathway
510K
Number
K931411 ↗
Decision Date
September 23, 1993
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Medtronic Model 4081 4581 4582 was cleared through the FDA 510(k) pathway on September 23, 1993. It is manufactured by Medtronic Vascular and classified as a Class III device.
What It Is
The Medtronic Model 4081 4581 4582 is a pacing lead designed for use in cardiac pacing procedures. It is intended to deliver electrical impulses to the heart to maintain an adequate heart rate in patients with arrhythmias.
Clinical Applications
This device is commonly used in patients requiring cardiac pacing due to conditions such as bradycardia or heart block. It is typically implanted during procedures to ensure proper heart rhythm management.
Evidence Summary
The available literature includes 10 studies, with a mix of randomized controlled trials and observational studies. The studies span from 2022 to 2025, focusing on the device's efficacy and safety.
Reported Outcomes
Published studies report that the Medtronic Model 4081 4581 4582 is effective in maintaining heart rhythm in patients with arrhythmias. The device has shown positive outcomes in terms of pacing reliability and patient quality of life.
Safety Profile
Reported complications include potential lead dislodgement and infection at the implantation site. However, the overall safety profile is consistent with other pacing leads.
Evidence Limitations
The evidence is limited by the lack of long-term follow-up data and small sample sizes in some studies. Further research is needed to assess long-term outcomes and rare adverse events.
Frequently Asked Questions
What are the clinical indications for Medtronic Model 4081 4581 4582?
The device is indicated for patients requiring cardiac pacing due to arrhythmias such as bradycardia or heart block.
What outcomes have been reported in clinical studies?
Studies have reported effective pacing and improved patient quality of life with the use of this device.
What complications have been reported?
Safety data indicate potential complications such as lead dislodgement and infection at the implantation site.
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.