đź“Š Evidence-Based Reference
medtronic 6304 6305 6306 6506 6506w temp pacin
Medtronic Vascular
Summary: The Medtronic 6304 6305 6306 6506 6506w Temp Pacin is a temporary pacing device used in cardiovascular procedures. It is FDA-cleared and linked to 10 studies, providing insights into its clinical use and safety.
FDA Clearance Information
Pathway
510K
Number
K844959 ↗
Decision Date
January 10, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device received FDA clearance through the 510(k) pathway on January 10, 1985. It is manufactured by Medtronic Vascular and classified as a Class III device.
What It Is
The Medtronic 6304 6305 6306 6506 6506w Temp Pacin is a temporary pacemaker designed for use in patients requiring short-term cardiac pacing. It is intended for use in various cardiovascular procedures where temporary pacing is necessary.
Clinical Applications
This device is commonly used in clinical scenarios such as post-operative cardiac surgery, during catheterization procedures, and in cases of transient heart block. It provides temporary pacing support to stabilize heart rhythms.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs, prospective, and retrospective analyses. These studies span from 2024 to 2025, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that the Medtronic temporary pacemaker effectively stabilizes heart rhythms in acute settings. It has been associated with improved procedural outcomes in cardiac surgeries and catheterization procedures. The device's efficacy in maintaining temporary pacing has been consistently demonstrated across multiple studies.
Safety Profile
Reported complications include device-related infections and lead dislodgement. However, these events are relatively rare and are consistent with the known risks associated with temporary pacing devices.
Evidence Limitations
The evidence is limited by the small sample sizes and the short duration of follow-up in some studies. Further research is needed to evaluate long-term outcomes and to compare the device's performance with other temporary pacing solutions.
Frequently Asked Questions
What are the clinical indications for Medtronic 6304 6305 6306 6506 6506w Temp Pacin?
The device is indicated for temporary cardiac pacing in patients undergoing cardiac surgery, catheterization, or experiencing transient heart block.
What outcomes have been reported in clinical studies?
Studies have reported effective stabilization of heart rhythms and improved procedural outcomes in cardiac surgeries and catheterizations.
What complications have been reported?
Safety data indicate potential complications such as device-related infections and lead dislodgement, though these are relatively rare.
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.