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pace implant lead tined atrial j model 3290
Pace Medical
Summary: The Pace Implant Lead Tined Atrial J Model 3290 is a tined, atrial pacing lead used primarily for atrial pacing. Key evidence highlights favorable implantation data with low pacing thresholds and minimal complications.
FDA Clearance Information
Pathway
510K
Number
K864153 ↗
Decision Date
January 6, 1987
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on January 6, 1987. It is manufactured by Pace Medical and classified as a Class III device under product code DTB.
What It Is
The Pace Implant Lead Tined Atrial J Model 3290 is a tined, J-shaped atrial pacing lead designed for implantation in the atrium. It is used to maintain appropriate heart rhythm by delivering electrical impulses to the heart muscle.
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 often part of a pacemaker system to ensure effective cardiac pacing.
Evidence Summary
The available literature includes 10 studies, with a mix of clinical evaluations and performance assessments, conducted between 1997 and 1999. These studies provide insights into the device's efficacy and safety.
Reported Outcomes
Published studies report favorable pacing thresholds at implantation, with a median threshold of 0.6 V. The device demonstrates stable pacing impedance over time, contributing to its effective performance in clinical settings.
Safety Profile
Reported complications include a low rate of lead dislodgment and diaphragmatic pacing, which occasionally necessitated reoperation. Overall, the device has a favorable safety profile with minimal acute lead-related complications.
Evidence Limitations
The evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to evaluate long-term outcomes and compare the device's performance with newer pacing technologies.
Frequently Asked Questions
What are the clinical indications for Pace Implant Lead Tined Atrial J Model 3290?
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 report favorable pacing thresholds and stable pacing impedance, indicating effective performance in maintaining heart rhythm.
What complications have been reported?
Reported complications include low rates of lead dislodgment and diaphragmatic pacing, with minimal acute lead-related issues.
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.