📋 FDA Reference
Model a Unipolar Endocardial Lead
Cook Pacemaker
Summary: The Model A Unipolar Endocardial Lead is a cardiac device used in pacemaker systems to transmit electrical impulses to the heart. It is typically used by cardiologists in patients with arrhythmias.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K811879 ↗
Decision Date ?
August 3, 1981
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
This device was cleared through the FDA 510k pathway on August 3, 1981. Manufactured by Cook Pacemaker, it is classified as a Class III medical device.
What It Is
The Model A Unipolar Endocardial Lead is a component of a pacemaker system, designed to deliver electrical impulses directly to the heart muscle. It consists of a single electrode that contacts the endocardium, the inner lining of the heart. This lead is crucial for maintaining heart rhythm in patients with bradycardia or other rhythm disorders.
FDA-Cleared Indications
- Cardiac pacing in patients who require electrical stimulation because of a clinically significant bradyarrhythmia or conduction disorder.
- Use as an endocardial lead connected to a compatible pacemaker generator.
Clinical Applications
- Endocardial pacing for symptomatic bradycardia.
- Pacing in selected patients with heart block.
- Pacing in selected patients with sick sinus syndrome or other rhythm disorders requiring pacemaker support.
- Implantation as part of a single-lead pacemaker system by trained cardiac specialists.
Practical Considerations
- The lead must be positioned securely against the endocardium and connected to a compatible pacemaker generator.
- Unipolar systems use the lead electrode and the generator case as the pacing circuit; this can make sensing more susceptible to electrical interference than bipolar systems.
- Lead dimensions, connector compatibility and implantation technique must be confirmed in the applicable manufacturer documentation before use.
- MRI safety cannot be determined from the device name alone. Patients with this lead should be considered to have a non-MRI-conditional system unless the complete implanted system is specifically documented as MRI-conditional.
- Potential contraindications and precautions include infection, unsuitable venous access, inability to safely place the lead, or a pacemaker indication that is not supported by the applicable labeling.
Frequently Asked Questions
What is Model A Unipolar Endocardial Lead used for?
It is used to deliver electrical impulses to the heart in pacemaker systems, helping to regulate heart rhythm in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in the management of cardiac arrhythmias.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to arrhythmias such as heart block or slow heart rates.
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.