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Endocardial Atrial Pacing Lead M 6994
Medtronic Vascular
Summary: The endocardial atrial pacing lead M 6994 by Medtronic Vascular is a device used for cardiac pacing. It was FDA-cleared via the 510k pathway in 1978. Key evidence includes studies on pacing system malfunctions and comparisons with other pacing techniques.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K780623 ↗
Decision Date ?
July 28, 1978
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The endocardial atrial pacing lead M 6994 was cleared by the FDA through the 510k pathway on July 28, 1978. It is manufactured by Medtronic Vascular and classified as a Class 3 device.
What It Is
The endocardial atrial pacing lead M 6994 is designed for cardiac pacing, specifically targeting the atrial chamber of the heart. It is intended to manage arrhythmias by delivering electrical impulses to maintain a regular heart rhythm.
FDA-Cleared Indications
- Use as an endocardial atrial pacing lead for cardiac pacing.
- Deliver pacing stimuli to the atrial chamber when connected to a compatible pacemaker system.
Clinical Applications
- Atrial pacing as part of an implanted cardiac pacemaker system.
- Endocardial delivery of electrical impulses to the right atrium through a transvenous lead.
- Pacing support for selected patients with clinically indicated slow or abnormal heart rhythms, when an atrial pacing system is appropriate.
Evidence Summary
The available literature includes six studies ranging from case reports to randomized clinical trials. These studies span from 1997 to 2020, focusing on various aspects of pacing lead performance and outcomes.
Reported Outcomes
Published studies report that the endocardial atrial pacing lead M 6994 is effective in maintaining cardiac rhythm in patients with atrial arrhythmias. Some studies highlight its role in improving clinical status in patients who did not respond to conventional therapies.
Safety Profile
Reported complications include potential malfunctions due to external factors like electrical discharges. However, specific adverse events related to the device itself are not extensively documented in the provided evidence.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized trials. Further research is needed to fully understand the long-term safety and efficacy of the device in diverse patient populations.
Practical Considerations
- The lead must be compatible with the implanted pulse generator and pacing system; connector, polarity, sensing, and pacing requirements should be verified before implantation.
- Implantation generally requires venous access and fluoroscopic guidance, with the lead positioned in the right atrium and tested for sensing and pacing thresholds.
- The available lead dimensions, fixation method, and connector details should be confirmed from the original labeling or device records because this is a historical device cleared in 1978.
- MRI safety cannot be determined from the FDA record provided. Do not assume the lead is MRI-conditional; evaluate the complete implanted system and current manufacturer or institutional guidance.
- Potential complications include lead dislodgment, failure to capture or sense, arrhythmia, venous thrombosis, infection, perforation, and damage to the lead or connector.
Frequently Asked Questions
What are the clinical indications for endocardial atrial pacing lead M 6994?
The device is indicated for patients requiring atrial pacing, particularly in cases of atrial fibrillation or bradycardia.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of cardiac rhythm and improved clinical status in non-responders to conventional therapies.
What complications have been reported?
Reported complications include potential malfunctions due to external electrical discharges, with limited data on other adverse events.
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.