📊 Evidence-Based Reference
Temporary Myocardial Pacing Lead 6400
Medtronic Vascular
Summary: The Medtronic Model 6400 is a temporary myocardial pacing lead used post-cardiac surgery. Key evidence highlights its efficacy in maintaining myocardial stimulation thresholds and safety with no reported complications.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K810333 ↗
Decision Date ?
March 13, 1981
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Medtronic Model 6400 temporary myocardial pacing lead was cleared via the FDA 510(k) pathway on March 13, 1981. It is manufactured by Medtronic Vascular and classified as a Class III device.
What It Is
The Medtronic Model 6400 is a temporary myocardial pacing lead designed for use after cardiac operations. It facilitates temporary pacing by delivering electrical impulses to the heart muscle, ensuring adequate heart function during the postoperative period.
FDA-Cleared Indications
- Temporary myocardial pacing following cardiac surgery when temporary pacing support is clinically indicated.
Clinical Applications
- Temporary pacing support during the postoperative period after cardiac operations.
- Treatment of transient postoperative bradycardia or conduction disturbances requiring temporary myocardial stimulation.
- Management of selected postoperative arrhythmias when temporary pacing is needed.
Evidence Summary
The available literature includes three studies conducted between 1982 and 1983. These studies encompass various designs, including prospective and retrospective analyses, with a total sample size of approximately 109 patients.
Reported Outcomes
Published studies report that the Medtronic Model 6400 maintains myocardial stimulation thresholds effectively, with initial median thresholds at 0.4 mA and maximum at 2.3 mA. Stimulation resistance was initially 875 ohms, with a subsequent increase noted. The mean electrogram amplitude was recorded at 7.35 mV.
Safety Profile
Reported complications include none, as studies did not identify any adverse events associated with the use of the Medtronic Model 6400. This suggests a favorable safety profile in the studied population.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of randomized controlled trials. Further research is needed to confirm long-term safety and efficacy across diverse patient populations.
Practical Considerations
- The lead is intended for temporary use and is placed on or in contact with the myocardium during cardiac surgery; it is connected to an external temporary pacemaker.
- Use requires compatibility with the external pacing generator, connecting cables, and the clinician's pacing system.
- The pacing threshold should be checked during use because thresholds can change after surgery and may affect capture.
- This is not an implanted long-term pacemaker lead. MRI eligibility should not be assumed; the complete temporary lead and pacing system must be evaluated, and an external pacemaker may be unsafe in the MRI environment.
- Potential complications include failure to capture, lead dislodgment or malfunction, bleeding, infection, arrhythmia, and myocardial or tissue injury.
Frequently Asked Questions
What are the clinical indications for temporary myocardial pacing lead 6400?
The device is indicated for temporary pacing support in patients undergoing cardiac surgery, particularly for managing transient arrhythmias or conduction disturbances.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of myocardial stimulation thresholds and resistance, with no complications noted.
What complications have been reported?
Safety data from evidence indicate no reported complications associated with the use of this device.
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.