📊 Evidence-Based Reference
Electrode Pacemaker Permanent Temporary
Intermedics
Summary: The electrode pacemaker by Intermedics is used for both permanent and temporary cardiac pacing. It is FDA-cleared and primarily used in managing arrhythmias. Key evidence highlights its role in reducing complications during procedures like TAVR.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K870357 ↗
Decision Date ?
May 21, 1987
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The device was cleared through the FDA 510k pathway on May 21, 1987. Manufactured by Intermedics, it is classified as a Class 3 device under product code DTB.
What It Is
The electrode pacemaker is a medical device that delivers electrical impulses to the heart to regulate its rhythm. It is used in both permanent and temporary settings to manage arrhythmias and ensure adequate heart rate.
FDA-Cleared Indications
- Cardiac pacing when electrical stimulation is needed to treat or prevent an inadequate heart rate.
- Temporary cardiac pacing during cardiac procedures or when short-term rhythm support is required.
- Permanent cardiac pacing for patients with chronic rhythm or conduction disorders requiring long-term pacing.
Clinical Applications
- Temporary pacing during cardiac procedures, including procedures in which transient heart block or bradycardia may occur.
- Temporary pacing after cardiac intervention when short-term support is clinically necessary.
- Permanent pacing for selected patients with symptomatic bradycardia or persistent conduction-system disease.
- Use as part of a compatible pacemaker system to deliver electrical stimulation to the heart.
Evidence Summary
The literature includes 12 studies, ranging from randomized controlled trials to case series, published between 2014 and 2023. These studies explore the device's efficacy and safety in various clinical settings.
Reported Outcomes
Published studies report that the electrode pacemaker is effective in managing arrhythmias during procedures like TAVR. It has been shown to maintain adequate heart rates and reduce the incidence of conduction abnormalities post-procedure.
Safety Profile
Reported complications include cardiac tamponade from pacemaker perforation and lead migration. These are rare but serious events associated with temporary pacemaker use.
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 compare efficacy with newer devices.
Practical Considerations
- The electrode must be matched with a compatible pacemaker generator, connector, lead configuration and pacing system.
- Temporary and permanent pacing require different placement, fixation and monitoring strategies; the treating cardiac team determines the appropriate configuration.
- Placement requires imaging and electrical testing to confirm the electrode is positioned correctly and has acceptable sensing and capture thresholds.
- MRI safety cannot be assumed from this historical FDA record. MRI eligibility depends on the complete implanted system and its labeling; older systems may be contraindicated.
- Potential complications include bleeding, infection, vessel or heart-wall injury, lead displacement, failure to capture or sense, arrhythmia and thrombosis.
Frequently Asked Questions
What are the clinical indications for electrode pacemaker permanent temporary?
The device is indicated for managing arrhythmias, particularly during procedures like TAVR, and for patients with chronic bradyarrhythmias.
What outcomes have been reported in clinical studies?
Studies report effective management of arrhythmias and maintenance of heart rate during cardiac procedures, with reduced conduction abnormalities post-TAVR.
What complications have been reported?
Safety data indicate complications such as cardiac tamponade and lead migration, though these are rare occurrences.
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.