📊 Evidence-Based Reference
Electrode Pacemaker Permanent
Pacesetter Systems
Summary: The electrode pacemaker permanent by Pacesetter Systems is a cardiac device used to manage arrhythmias. Key evidence highlights its role in reducing pacemaker requirements post-surgery and managing complications like infections.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K810139 ↗
Decision Date ?
November 27, 1981
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The electrode pacemaker permanent was cleared by the FDA through the 510k pathway on November 27, 1981. It is manufactured by Pacesetter Systems and classified as a Class III device.
What It Is
The electrode pacemaker permanent is a device designed to regulate heart rhythms by delivering electrical impulses to the heart muscle. It is primarily used in patients with arrhythmias to maintain adequate heart rate and rhythm.
FDA-Cleared Indications
- Use in a permanent cardiac pacing system for patients with symptomatic bradycardia or other rhythm disorders requiring pacing.
- Use to deliver electrical stimulation to the heart when the native cardiac rhythm is inadequate.
- Use with a compatible permanent pacemaker generator as part of an implanted cardiac pacing system.
Clinical Applications
- Permanent cardiac pacing for clinically significant slow heart rates.
- Long-term pacing support for selected conduction disorders, such as heart block, when a physician determines pacing is indicated.
- Pacing support for selected patients with atrial fibrillation or other arrhythmias associated with an inadequate ventricular rate.
- Implantation of a cardiac pacing lead with a compatible pacemaker generator.
Reported off-label uses
- Use of pacing systems for selected heart-failure patients as part of cardiac resynchronization therapy, when the specific lead and system labeling supports the application.
- Temporary external connection of a pacing lead during selected procedures or postoperative management, when clinically appropriate.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The literature includes 15 studies ranging from 2019 to 2023, encompassing various study types such as RCTs, case series, and retrospective analyses. These studies explore the device's efficacy and safety in different clinical scenarios.
Reported Outcomes
Published studies report that the electrode pacemaker permanent effectively manages arrhythmias and reduces the need for additional pacemaker interventions post-surgery. It has been shown to stabilize heart rhythms and improve patient outcomes in cases of cardiac malfunction.
Safety Profile
Reported complications include pacemaker malfunction, infections at the implantation site, and cardiac tamponade. These adverse events highlight the need for careful monitoring and management in clinical practice.
Evidence Limitations
Current evidence is limited by the lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and optimize patient selection criteria for this device.
Practical Considerations
- The lead must be matched to the pacemaker generator and implanted configuration; connector standards, lead polarity, fixation method, length, and diameter must be confirmed before use.
- Implantation generally requires venous access, fluoroscopic or other imaging guidance, and positioning in the right atrium, right ventricle, or another labeled cardiac location.
- MRI safety cannot be assumed for this historical device. The complete implanted system must be checked for MRI-conditional labeling; older systems may require MRI avoidance or a specialized risk assessment.
- Potential complications include bleeding, infection, lead dislodgement, venous thrombosis, pneumothorax, cardiac perforation, arrhythmia, and lead or generator malfunction.
- The electrode is not a stand-alone treatment and requires a compatible pacemaker generator, programming, follow-up testing, and eventual replacement of the generator or lead if performance or battery life declines.
Frequently Asked Questions
What are the clinical indications for electrode pacemaker permanent?
The device is indicated for patients with arrhythmias requiring long-term cardiac rhythm management, as detailed in the FDA documentation.
What outcomes have been reported in clinical studies?
Studies report effective management of arrhythmias and reduced need for additional interventions, with improved patient outcomes in specific scenarios.
What complications have been reported?
Safety data indicate complications such as pacemaker malfunction, infections, and cardiac tamponade, necessitating careful clinical management.
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.