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electrode pacemaker permanent
Pacesetter Systems
Summary: The electrode pacemaker permanent by Pacesetter Systems is a cardiac device used to manage arrhythmias. Key evidence highlights its role in reducing pacemaker requirements post-surgery and managing complications like infections.
FDA Clearance Information
Pathway
510K
Number
K810139 ↗
Decision Date
November 27, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The electrode pacemaker permanent was cleared by the FDA through the 510k pathway on November 27, 1981. It is manufactured by Pacesetter Systems and classified as a Class III device.
What It Is
The electrode pacemaker permanent is a device designed to regulate heart rhythms by delivering electrical impulses to the heart muscle. It is primarily used in patients with arrhythmias to maintain adequate heart rate and rhythm.
Clinical Applications
This device is commonly used in patients with bradycardia, atrial fibrillation, and other arrhythmias. It is often implanted in individuals who require long-term cardiac rhythm management.
Evidence Summary
The literature includes 15 studies ranging from 2019 to 2023, encompassing various study types such as RCTs, case series, and retrospective analyses. These studies explore the device's efficacy and safety in different clinical scenarios.
Reported Outcomes
Published studies report that the electrode pacemaker permanent effectively manages arrhythmias and reduces the need for additional pacemaker interventions post-surgery. It has been shown to stabilize heart rhythms and improve patient outcomes in cases of cardiac malfunction.
Safety Profile
Reported complications include pacemaker malfunction, infections at the implantation site, and cardiac tamponade. These adverse events highlight the need for careful monitoring and management in clinical practice.
Evidence Limitations
Current evidence is limited by the lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and optimize patient selection criteria for this device.
Frequently Asked Questions
What are the clinical indications for electrode pacemaker permanent?
The device is indicated for patients with arrhythmias requiring long-term cardiac rhythm management, as detailed in the FDA documentation.
What outcomes have been reported in clinical studies?
Studies report effective management of arrhythmias and reduced need for additional interventions, with improved patient outcomes in specific scenarios.
What complications have been reported?
Safety data indicate complications such as pacemaker malfunction, infections, and cardiac tamponade, necessitating careful clinical management.
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.