đź“Š Evidence-Based Reference
medtronic 6957j
Medtronic Vascular
Summary: The Medtronic 6957J is an atrial lead used in cardiac pacing. It is primarily used for patients requiring permanent pacemaker implantation. Key evidence highlights its long-term functional integrity and acute pacing threshold changes.
FDA Clearance Information
Pathway
510K
Number
K843707 ↗
Decision Date
January 8, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Medtronic 6957J was cleared through the FDA 510(k) pathway on January 8, 1985. It is manufactured by Medtronic Vascular and classified as a Class 3 device.
What It Is
The Medtronic 6957J is a unipolar screw-in atrial lead designed for permanent pacemaker implantation. It facilitates electrical conduction between the pacemaker and the heart, ensuring effective cardiac pacing.
Clinical Applications
This device is commonly used in patients requiring atrial pacing due to conditions like atrial fibrillation or bradycardia. It is typically implanted in scenarios where reliable atrial sensing and pacing are critical.
Evidence Summary
The available literature includes four studies, primarily retrospective and randomized controlled trials, conducted between 1988 and 1991. These studies focus on the device's functional integrity and pacing characteristics.
Reported Outcomes
Published studies report that the Medtronic 6957J maintains long-term functional integrity with a high percentage of leads continuing to function satisfactorily. Acute changes in pacing threshold and R-wave amplitude were observed, with significant improvements noted shortly after implantation.
Safety Profile
Reported complications include concerns about lead dislodgement and tissue trauma associated with myocardial screw-helix fixation. However, specific adverse events were not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the retrospective nature of some studies and a lack of detailed safety data. Further research is needed to explore long-term outcomes and potential complications in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Medtronic 6957J?
The Medtronic 6957J is indicated for patients requiring atrial pacing, such as those with atrial fibrillation or bradycardia.
What outcomes have been reported in clinical studies?
Studies report long-term functional integrity and acute improvements in pacing thresholds and R-wave amplitude post-implantation.
What complications have been reported?
Reported complications include potential lead dislodgement and tissue trauma, though specific adverse events were not detailed.
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.