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pacemaker electrode
Daig
Summary: The pacemaker electrode by Daig is a device used in cardiac pacing. It is primarily used for managing arrhythmias. Key evidence highlights issues such as electrode rupture and dislocation.
FDA Clearance Information
Pathway
510K
Number
K800352 ↗
Decision Date
May 28, 1980
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The pacemaker electrode by Daig was cleared via the FDA 510k pathway on May 28, 1980. It is classified as a Class 3 device, indicating a higher level of regulatory control.
What It Is
The pacemaker electrode is a component of cardiac pacemakers, designed to deliver electrical impulses to the heart to maintain an adequate heart rate. It is used in patients with arrhythmias to ensure proper cardiac function.
Clinical Applications
Commonly used in scenarios involving arrhythmias such as bradycardia, the pacemaker electrode is implanted to ensure consistent heart rhythm. It is often placed via subclavian or axillary vein puncture.
Evidence Summary
The literature includes 14 studies ranging from case reports to retrospective analyses, published between 1979 and 2023. These studies explore various aspects of electrode use, including complications and procedural techniques.
Reported Outcomes
Published studies report that pacemaker electrodes are effective in maintaining heart rhythm in patients with arrhythmias. However, issues such as electrode rupture and dislocation have been noted, impacting device performance.
Safety Profile
Reported complications include electrode rupture, dislocation, and unintended muscle stimulation. These issues can lead to poor pacemaker perception and pacing, as well as misinterpretation of symptoms in seizure-prone patients.
Evidence Limitations
The evidence is limited by the small number of studies focusing on specific complications. Further research is needed to explore long-term outcomes and the impact of individual anatomical differences on electrode performance.
Frequently Asked Questions
What are the clinical indications for pacemaker electrode?
The pacemaker electrode is indicated for use in patients with arrhythmias requiring cardiac pacing, as detailed in FDA documentation.
What outcomes have been reported in clinical studies?
Studies report effective heart rhythm management but also note complications such as electrode rupture and dislocation.
What complications have been reported?
Safety data indicate complications including electrode rupture, dislocation, and unintended muscle stimulation.
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.