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ventricular lead model 6959
Medtronic Vascular
Summary: The ventricular lead model 6959 by Medtronic Vascular is used for ventricular pacing. Key evidence highlights its use in permanent endocardial pacing and reports on complications such as detachment of the active fixation helix.
FDA Clearance Information
Pathway
510K
Number
K790143 ↗
Decision Date
September 19, 1979
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The ventricular lead model 6959 was cleared via the FDA 510k pathway on September 19, 1979. It is manufactured by Medtronic Vascular and classified as a Class 3 device.
What It Is
The ventricular lead model 6959 is a transvenous unipolar screw-in lead designed for permanent ventricular endocardial pacing. It utilizes an active fixation mechanism to secure the lead within the heart tissue.
Clinical Applications
This device is commonly used in scenarios requiring permanent ventricular pacing, such as in patients with bradycardia or heart block. It is particularly useful in cases where stable lead fixation is critical.
Evidence Summary
The available literature includes two studies, with publication years ranging from 1983 to 2001. These studies encompass various methodologies, including retrospective and case series analyses.
Reported Outcomes
Published studies report that the ventricular lead model 6959 is effective in providing stable ventricular pacing. The use of active fixation electrodes has been noted as a significant advancement in pacing technology.
Safety Profile
Reported complications include the detachment of the pacemaker's active fixation helix, which can lead to lead displacement and loss of pacing. This highlights the importance of careful monitoring and follow-up.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of recent data. Further research is needed to evaluate long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for ventricular lead model 6959?
The device is indicated for permanent ventricular pacing in patients with conditions such as bradycardia or heart block.
What outcomes have been reported in clinical studies?
Studies report effective ventricular pacing and highlight the advancement of active fixation electrodes.
What complications have been reported?
Safety data indicate complications such as detachment of the active fixation helix, leading to potential lead displacement.
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.