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electrode lead construction
Telectronics
Summary: Electrode lead construction by Telectronics is used in implantable cardiac devices. It was FDA cleared via 510k in 1984. Key evidence highlights artifact issues in cardiac imaging.
FDA Clearance Information
Pathway
510K
Number
K834533 ↗
Decision Date
January 30, 1984
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The electrode lead construction by Telectronics was cleared by the FDA through the 510k pathway on January 30, 1984. It is classified as a Class 3 device under product code DTB.
What It Is
The electrode lead construction is a component used in implantable cardiac devices, such as pacemakers and defibrillators. It facilitates electrical conduction within the heart to manage arrhythmias.
Clinical Applications
This device is commonly used in patients requiring cardiac rhythm management, particularly those with arrhythmias that necessitate the use of pacemakers or implantable cardioverter-defibrillators (ICDs).
Evidence Summary
The literature includes 15 studies, with a mix of study types, focusing on the device's performance and implications in clinical settings. The studies span from 2022 to 2024.
Reported Outcomes
Published studies report that electrode leads can cause artifacts in cardiac CT imaging, potentially obscuring diagnostic views. The studies emphasize the need for advanced imaging techniques to mitigate these artifacts.
Safety Profile
Reported complications include imaging artifacts in cardiac CT scans due to the presence of electrode leads. These artifacts can interfere with the accurate assessment of cardiac structures.
Evidence Limitations
The evidence is limited by a focus on imaging artifacts, with less emphasis on long-term clinical outcomes. Further research is needed to explore the device's performance in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for electrode lead construction?
The device is indicated for use in patients requiring cardiac rhythm management, such as those with arrhythmias needing pacemakers or ICDs.
What outcomes have been reported in clinical studies?
Studies have reported issues with imaging artifacts in cardiac CT scans caused by electrode leads, affecting diagnostic accuracy.
What complications have been reported?
Safety data indicate that electrode leads can cause significant imaging artifacts in cardiac CT, potentially obscuring important diagnostic information.
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.