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Model 479-01 Pacing Lead
Intermedics
Summary: The Model 479-01 pacing lead is a cardiac device used for pacing the heart. It is primarily used by cardiologists in patients requiring cardiac rhythm management.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K844271 ↗
Decision Date ?
March 28, 1985
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Model 479-01 pacing lead was cleared through the FDA 510(k) pathway on March 28, 1985. Manufactured by Intermedics, it is classified as a Class 3 device.
What It Is
The Model 479-01 pacing lead is a medical device designed to deliver electrical impulses to the heart to maintain an adequate heart rate. It is typically used in conjunction with a pacemaker, which generates the impulses that the lead then delivers to the heart muscle. This device is crucial for patients with arrhythmias or heart block, ensuring that their heart maintains a regular rhythm.
FDA-Cleared Indications
- Use as part of a cardiac pacemaker system to deliver electrical stimulation to the heart.
- Cardiac pacing in patients with clinically significant bradycardia or heart block, when pacing therapy is indicated.
Clinical Applications
- Implantation with a pacemaker generator for long-term cardiac rhythm management.
- Delivery of pacing impulses to the heart muscle during pacemaker therapy.
- Treatment of symptomatic slow heart rates when a permanent pacemaker is clinically indicated.
- Pacing support for patients with conduction disorders such as heart block.
Practical Considerations
- The lead must be implanted and connected to a compatible pacemaker generator by clinicians trained in cardiac-device procedures.
- Available lead lengths and configuration details should be confirmed in the manufacturer’s labeling and the specific device record before implantation.
- Lead placement, electrical measurements, and connection integrity should be verified during implantation and follow-up.
- MRI safety cannot be assumed for this historical lead or for a complete pacemaker system; MRI eligibility requires review of the exact lead, generator, and current labeling.
- Potential complications include infection, bleeding, lead dislodgement, lead fracture or insulation failure, venous obstruction, cardiac perforation, and abnormal pacing or sensing.
Frequently Asked Questions
What is the Model 479-01 pacing lead used for?
It is used to deliver electrical impulses to the heart to maintain a regular heartbeat in patients with arrhythmias.
What specialties typically use this device?
Cardiologists, especially those specializing in electrophysiology and interventional cardiology, typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to conditions like bradycardia or heart block.
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.