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medtronic model 4016a endocardial pacing lead
Medtronic Vascular
Summary: The Medtronic Model 4016A is an endocardial pacing lead used primarily for cardiac pacing. It is FDA-cleared and supported by 10 studies, highlighting its use in conduction system pacing and potential complications.
FDA Clearance Information
Pathway
510K
Number
K873962 ↗
Decision Date
February 2, 1988
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Medtronic Model 4016A Endocardial Pacing Lead was cleared by the FDA via the 510(k) pathway on February 2, 1988. It is manufactured by Medtronic Vascular and classified as a Class III device.
What It Is
The Medtronic Model 4016A is an endocardial pacing lead designed for cardiac pacing applications. It is intended to provide electrical stimulation to the heart to maintain an adequate heart rate in patients with arrhythmias.
Clinical Applications
This device is commonly used in scenarios requiring cardiac pacing, such as in patients with atrioventricular block or other conduction system disorders. It is often utilized in both adult and pediatric populations where endocardial pacing is indicated.
Evidence Summary
The available literature includes 10 studies, comprising case reports, RCTs, and retrospective analyses, published between 2024 and 2025. These studies explore various aspects of pacing lead use, including implantation techniques and extraction procedures.
Reported Outcomes
Published studies report that the Medtronic Model 4016A is effective in maintaining cardiac rhythm in patients with conduction system disorders. Outcomes include successful pacing in pediatric and adult patients, with some studies highlighting the feasibility of epicardial implantation.
Safety Profile
Reported complications include challenges in lead extraction and potential for endocardial entanglement. Some studies note the need for careful consideration of lead placement to avoid adverse events.
Evidence Limitations
Current evidence is limited by the small sample sizes and the lack of long-term outcome data. Further research is needed to better understand the long-term safety and efficacy of the device, particularly in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Medtronic Model 4016A Endocardial Pacing Lead?
The device is indicated for use in patients requiring cardiac pacing, such as those with atrioventricular block or other conduction disorders.
What outcomes have been reported in clinical studies?
Studies report effective pacing outcomes, including successful implantation and maintenance of cardiac rhythm in both adult and pediatric patients.
What complications have been reported?
Safety data indicate potential complications such as lead extraction challenges and endocardial entanglement, necessitating careful procedural planning.
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.