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permanent and temp pacemaker electrode lead ada
Medtronic Vascular
Summary: The permanent and temporary pacemaker electrode lead ADA by Medtronic Vascular is a device used in cardiac pacing. It is FDA 510k cleared and primarily used for maintaining heart rhythm. Current evidence includes two studies, focusing on leadless pacemaker outcomes.
FDA Clearance Information
Pathway
510K
Number
K895136 ↗
Decision Date
February 8, 1990
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared through the FDA 510k pathway on February 8, 1990. It is manufactured by Medtronic Vascular and classified as a Class 3 device under product code DTB.
What It Is
The permanent and temporary pacemaker electrode lead ADA is designed for cardiac pacing, providing electrical stimulation to maintain heart rhythm. It is used in both temporary and permanent pacemaker systems.
Clinical Applications
This device is commonly used in patients requiring cardiac pacing due to arrhythmias or heart block. It is applicable in both acute settings for temporary pacing and chronic management with permanent pacemakers.
Evidence Summary
The available literature includes two studies, one from 2023, focusing on leadless pacemaker outcomes. These studies vary in design, including systematic reviews and randomized trials.
Reported Outcomes
Published studies report that leadless pacemakers, as an alternative to traditional pacemakers, have shown promising outcomes in terms of efficacy. However, consolidated data on emergency implantation scenarios is lacking.
Safety Profile
Reported complications include typical risks associated with pacemaker implantation, such as infection and lead dislodgement. Specific safety data from the provided studies is limited.
Evidence Limitations
The evidence base is limited, with a need for more comprehensive data on leadless pacemaker use in emergency settings. Further research is required to consolidate safety and efficacy findings.
Frequently Asked Questions
What are the clinical indications for permanent and temp pacemaker electrode lead ADA?
The device is indicated for use in patients requiring cardiac pacing due to arrhythmias or heart block.
What outcomes have been reported in clinical studies?
Studies report promising outcomes for leadless pacemakers, though data on emergency use is limited.
What complications have been reported?
Safety data indicates risks such as infection and lead dislodgement, typical of pacemaker implantation.
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.