đź“‹ FDA Reference
medtronic model 4951p
Medtronic Vascular
Summary: The Medtronic Model 4951P is an epicardial pacing electrode used in cardiac pacing, primarily in pediatric patients. It is utilized by cardiologists and cardiac surgeons.
FDA Clearance Information
Pathway
510K
Number
K881810 ↗
Decision Date
October 13, 1988
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Medtronic Model 4951P was cleared via the FDA 510(k) process on October 13, 1988. It is manufactured by Medtronic Vascular and classified as a Class III device.
What It Is
The Medtronic Model 4951P is an epicardial pacing electrode designed for cardiac pacing. It features a barb design for epimyocardial insertion, which facilitates stable placement on the heart's surface. This device is particularly useful in pediatric patients where transvenous pacing may not be feasible.
Clinical Applications
This device is commonly used in pediatric cardiology and cardiac surgery settings for patients requiring epicardial pacing. It is suitable for use in children and young adults who need temporary or permanent pacing due to congenital heart defects or post-surgical conditions. The device is typically used in hospital settings, including operating rooms and cardiac care units.
Indications for Use
The Medtronic Model 4951P is indicated for use in patients requiring epicardial pacing, particularly those who cannot undergo transvenous pacing. It is often used in pediatric patients with congenital heart conditions or after cardiac surgery.
Practical Considerations
The Medtronic Model 4951P is designed for epicardial insertion and is compatible with standard pacing systems. Clinicians should be familiar with epicardial pacing techniques and ensure proper electrode placement to avoid complications.
Related Literature
The linked study evaluated the performance of the Medtronic Model 4951P electrode in comparison to a steroid-eluting counterpart in 13 children. The study found comparable performance in terms of sensing and pacing thresholds between the two designs. However, the study was limited by its small sample size and short follow-up duration, which may affect the generalizability of the findings.
Frequently Asked Questions
What is Medtronic Model 4951P used for?
It is used for epicardial pacing in patients, particularly in pediatric cases where transvenous pacing is not suitable.
What specialties typically use this device?
Cardiologists and cardiac surgeons, especially those working in pediatric cardiology, use this device.
What are the FDA-cleared indications?
It is indicated for epicardial pacing in patients who require it, especially when transvenous pacing is not an option.
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.