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electrode pacemaker permanent
Pacesetter Systems
Summary: The electrode pacemaker permanent by Pacesetter Systems is a device used for cardiac pacing. It is primarily used in patients with arrhythmias requiring permanent pacing. Key evidence highlights its effectiveness in maintaining cardiac rhythm.
FDA Clearance Information
Pathway
510K
Number
K810582 ↗
Decision Date
March 13, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The electrode pacemaker permanent was cleared by the FDA via the 510k pathway on March 13, 1981. It is manufactured by Pacesetter Systems and classified as a Class 3 device.
What It Is
The electrode pacemaker permanent is a medical device designed to provide electrical stimulation to the heart to maintain an adequate heart rate in patients with arrhythmias. It consists of a pulse generator and leads that deliver electrical impulses to the heart muscle.
Clinical Applications
This device is commonly used in patients with bradycardia or heart block who require long-term cardiac pacing. It is also indicated for patients with certain types of arrhythmias that do not respond to medication.
Evidence Summary
The available literature includes 15 studies, encompassing various study types such as RCTs, case series, and retrospective analyses. These studies span from 2018 to 2023, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that the electrode pacemaker permanent effectively maintains cardiac rhythm in patients with arrhythmias. It has been shown to reduce the need for additional interventions in patients undergoing concomitant surgeries for atrial fibrillation.
Safety Profile
Reported complications include pacemaker malfunction, which can lead to inadequate pacing and hemodynamic instability. Cardiac tamponade has also been noted as a potential adverse event following implantation.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and device performance in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for electrode pacemaker permanent?
The device is indicated for patients with bradycardia, heart block, and certain arrhythmias requiring permanent pacing.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of cardiac rhythm and reduced need for additional interventions in surgical patients.
What complications have been reported?
Safety data indicate risks of pacemaker malfunction and cardiac tamponade post-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.