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Permanent Endocard Unipolar Tined Lead
Diag
Summary: The permanent endocard unipolar tined lead is a cardiac device used for pacing the heart. It is primarily used by cardiologists in patients requiring long-term cardiac pacing.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K812905 ↗
Decision Date ?
February 4, 1982
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The permanent endocard unipolar tined lead was cleared through the FDA 510(k) pathway on February 4, 1982. Manufactured by Diag, it is a Class III medical device.
What It Is
This device is a unipolar tined lead designed for permanent implantation in the heart. It functions by delivering electrical impulses to stimulate heart contractions, ensuring proper cardiac rhythm. The tined design helps secure the lead in place within the heart tissue, reducing the risk of displacement.
FDA-Cleared Indications
- Permanent cardiac pacing in patients whose natural cardiac pacing system does not provide an adequate heart rate or rhythm.
- Use as an endocardial pacing lead connected to a compatible cardiac pacemaker system.
Clinical Applications
- Permanent pacing for symptomatic bradycardia.
- Permanent pacing for heart block or other disorders of electrical conduction.
- Permanent pacing for sick sinus syndrome or other conditions causing inadequate sinus-node function.
- Endocardial placement of a pacing lead within a cardiac chamber as part of a pacemaker implantation.
Practical Considerations
- The lead size and configuration must match the patient’s cardiac anatomy and the compatible pacemaker generator.
- Implantation requires fluoroscopic or other appropriate imaging guidance, electrical testing, and confirmation of stable lead position.
- The tined tip is intended to help secure the lead, but lead displacement, fracture, insulation failure, or loss of pacing function can occur.
- MRI safety depends on the complete implanted system, including the generator, lead, and implantation conditions; this historical lead should not be assumed to be MRI-conditional.
- Potential contraindications and risks include infection, venous or cardiac perforation, bleeding, arrhythmia, thrombosis, and problems related to anesthesia or the pacemaker system.
Frequently Asked Questions
What is the permanent endocard unipolar tined lead used for?
It is used for permanent cardiac pacing in patients with conditions like bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists commonly use this device in cardiac care settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring permanent cardiac pacing due to impaired heart rhythm.
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.