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medtronic model 4058 pacing lead
Medtronic Vascular
Summary: The Medtronic Model 4058 is a pacing lead used for atrial pacing. It is primarily used in patients with atrial fibrillation and bradyarrhythmias. Key evidence highlights its role in synchronous atrial depolarization and potential suppression of reentrant arrhythmias.
FDA Clearance Information
Pathway
510K
Number
K883743 ↗
Decision Date
January 17, 1989
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Medtronic Model 4058 pacing lead was cleared by the FDA via the 510(k) pathway on January 17, 1989. It is manufactured by Medtronic Vascular and classified as a Class III device.
What It Is
The Medtronic Model 4058 is an active fixation pacing lead designed for atrial pacing. It is used to achieve synchronous depolarization of the atria, which can optimize atrioventricular timing and potentially suppress arrhythmias.
Clinical Applications
This device is commonly used in patients with paroxysmal atrial fibrillation and symptomatic bradyarrhythmias. It is particularly useful in scenarios where precise atrial pacing is required to manage arrhythmias.
Evidence Summary
The available literature includes three studies, with types ranging from randomized controlled trials to retrospective analyses. The studies span from 1995 to 1998, involving various patient populations.
Reported Outcomes
Published studies report that the Medtronic Model 4058 pacing lead can effectively achieve synchronous atrial depolarization, which may suppress reentrant arrhythmias. The lead's active fixation mechanism is associated with a low incidence of dislodgment and offers flexibility in atrial pacing site selection.
Safety Profile
Reported complications include the potential for higher stimulation thresholds with active-fixation leads. However, the addition of steroid elution has been shown to improve stimulation thresholds, mitigating some safety concerns.
Evidence Limitations
The evidence is limited by small sample sizes and a lack of large-scale randomized trials. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Medtronic Model 4058 pacing lead?
The device is indicated for atrial pacing in patients with atrial fibrillation and symptomatic bradyarrhythmias, as per FDA documentation.
What outcomes have been reported in clinical studies?
Studies report effective synchronous atrial depolarization and potential suppression of reentrant arrhythmias with the use of this lead.
What complications have been reported?
Safety data indicate potential for higher stimulation thresholds, though steroid elution can improve these thresholds.
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.