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Medtronic Model 6957
Medtronic Vascular
Summary: The Medtronic Model 6957 is a unipolar screw-in ventricular pacing lead used in cardiac pacing. Key evidence highlights its acute pacing threshold performance.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K791769 ↗
Decision Date ?
September 19, 1979
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Medtronic Model 6957 was cleared through the FDA 510(k) pathway on September 19, 1979. It is manufactured by Medtronic Vascular and classified as a Class III device.
What It Is
The Medtronic Model 6957 is a unipolar screw-in lead designed for ventricular pacing in patients requiring cardiac rhythm management. It is intended for permanent implantation to facilitate electrical conduction to the heart.
FDA-Cleared Indications
- Permanent ventricular pacing in patients who require cardiac rhythm management.
- Use as an implanted lead to establish electrical conduction between a pacemaker and the ventricle.
Clinical Applications
- Permanent ventricular pacing.
- Pacing support for patients with clinically significant bradycardia requiring a pacemaker.
- Ventricular lead placement during implantation of a compatible permanent pacemaker system.
Evidence Summary
The available literature includes four studies, with study types ranging from retrospective to prospective designs. The studies span from 1990 to 2026, providing insights into the device's performance and clinical outcomes.
Reported Outcomes
Published studies report that the Medtronic Model 6957 exhibits an acute ventricular pacing threshold of 0.84 volts with a standard deviation of 0.17 volts. Comparative studies with tined leads showed differences in pacing thresholds.
Safety Profile
Reported complications include changes in pacing threshold and R- or P-wave amplitude during the initial implantation period. No specific adverse events were detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Practical Considerations
- The lead is unipolar and uses a screw-in fixation mechanism; it must be connected to a compatible pacemaker generator.
- Placement requires transvenous access and imaging or fluoroscopic guidance, followed by electrical testing of sensing and pacing thresholds.
- The available record does not provide lead length, diameter, connector specifications, or a complete compatibility list; these details should be confirmed in the original labeling or manufacturer documentation.
- MRI safety should not be assumed. Older pacing leads may not be labeled for MRI, and the complete implanted pacemaker system must be evaluated before an MRI examination.
- Contraindications and precautions include infection, unsuitable venous access, inability to safely position the lead, and patient factors that make permanent pacemaker implantation inappropriate.
Frequently Asked Questions
What are the clinical indications for Medtronic Model 6957?
The device is indicated for use in patients requiring ventricular pacing, such as those with sick sinus syndrome or high-grade AV block.
What outcomes have been reported in clinical studies?
Studies have reported an acute ventricular pacing threshold of 0.84 volts, indicating effective pacing performance.
What complications have been reported?
Safety data indicate changes in pacing threshold and R- or P-wave amplitude during initial implantation, with no specific adverse events 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.