đź“‹ FDA Reference
Model 436-01 Biopore Implantable Pacing Lead
Intermedics
Summary: The Model 436-01 Biopore Implantable Pacing Lead is used in cardiac pacing systems to deliver electrical impulses to the heart. It is primarily used by cardiologists and electrophysiologists in patients requiring cardiac rhythm management.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K862051 ↗
Decision Date ?
January 6, 1987
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Model 436-01 Biopore Implantable Pacing Lead was cleared through the FDA 510(k) pathway on January 6, 1987. Manufactured by Intermedics, it is classified as a Class III device under product code DTB.
What It Is
The Model 436-01 Biopore Implantable Pacing Lead is a medical device designed to transmit electrical impulses from a pacemaker to the heart muscle, ensuring proper heart rhythm. It features a biopore design that enhances tissue in-growth, promoting stability and reducing the risk of lead dislodgement. This lead is typically implanted via a transvenous approach and is compatible with various pacemaker models.
FDA-Cleared Indications
- Use as a component of a cardiac pacing system when electrical stimulation of the heart is indicated.
- Use in patients requiring transvenous pacing for bradyarrhythmias or other rhythm disorders identified by the treating physician.
Clinical Applications
- Placement as a transvenous lead during implantation of a permanent pacemaker.
- Delivery of pacing impulses from a compatible pacemaker generator to cardiac tissue.
- Long-term cardiac rhythm management in patients who require permanent pacing support.
- Use in hospital or cardiac electrophysiology settings for patients undergoing pacemaker implantation or lead-related treatment.
Practical Considerations
- The lead must be matched with a compatible pacemaker generator and implanted using the manufacturer’s labeling and applicable pacing-system requirements.
- Available lead length and configuration should be selected according to the patient’s anatomy and intended cardiac chamber.
- Implantation generally requires venous access, fluoroscopic guidance, electrical testing, and fixation of the lead within the heart.
- MRI safety cannot be determined from the device name alone. This is an older pacing lead, and MRI eligibility depends on the complete implanted system and current manufacturer and institutional guidance.
- Potential complications include lead dislodgement, failure to capture or sense, venous injury or thrombosis, infection, perforation, arrhythmia, and the need for revision or removal.
Frequently Asked Questions
What is the Model 436-01 Biopore Implantable Pacing Lead used for?
It is used to deliver electrical impulses from a pacemaker to the heart to manage arrhythmias such as bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac rhythm management procedures.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to arrhythmias like bradycardia, ensuring stable and effective heart rhythm 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.