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unipolar atrial j pacing lead model 869
Pacesetter Systems
Summary: The unipolar atrial j pacing lead model 869 by Pacesetter Systems is a cardiac pacing device cleared by the FDA. It is primarily used for atrial pacing. Key evidence highlights its efficacy in maintaining pacing function.
FDA Clearance Information
Pathway
510K
Number
K831436 ↗
Decision Date
June 8, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The unipolar atrial j pacing lead model 869 was cleared through the FDA 510(k) pathway on June 8, 1983. Manufactured by Pacesetter Systems, it is classified as a Class III device.
What It Is
The unipolar atrial j pacing lead model 869 is a cardiac pacing lead designed for atrial pacing. It functions by delivering electrical impulses to the atrium to maintain heart rhythm, particularly in patients with atrial arrhythmias.
Clinical Applications
This device is commonly used in patients requiring atrial pacing due to conditions such as atrial fibrillation or other atrial arrhythmias. It is typically employed in settings where atrial pacing is indicated to maintain cardiac rhythm.
Evidence Summary
The available literature includes a mix of study types such as RCTs, prospective, and retrospective studies, with a total of 11 studies. The studies range from 1999 to 2025, providing insights into the device's performance and safety.
Reported Outcomes
Published studies report that the unipolar atrial j pacing lead model 869 effectively maintains atrial pacing function. It has been shown to provide reliable pacing in various clinical scenarios. The device's performance in terms of sensing and pacing characteristics has been positively evaluated in the literature.
Safety Profile
Reported complications include issues related to lead placement and long-term lead stability. Some studies have noted challenges in lead insertion and potential for lead dislodgement. Overall, the device is considered safe with manageable risks.
Evidence Limitations
Current evidence is limited by the small sample sizes and the lack of long-term follow-up data in some studies. Further research is needed to explore the device's performance in diverse patient populations and over extended periods.
Frequently Asked Questions
What are the clinical indications for unipolar atrial j pacing lead model 869?
The device is indicated for patients requiring atrial pacing, such as those with atrial fibrillation or other atrial arrhythmias.
What outcomes have been reported in clinical studies?
Studies have reported effective maintenance of atrial pacing function and reliable sensing and pacing characteristics.
What complications have been reported?
Reported complications include lead placement challenges and potential for lead dislodgement, but overall safety is considered manageable.
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.