📋 FDA Reference
Endocardial Screw-In Lead Model 1020t
Pacesetter Systems
Summary: The endocardial screw-in lead model 1020t is a cardiac device used in pacing therapies. It is primarily used by cardiologists to manage arrhythmias in patients requiring pacemaker implantation.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K895447 ↗
Decision Date ?
December 20, 1989
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The endocardial screw-in lead model 1020t was cleared through the FDA 510(k) pathway on December 20, 1989. Manufactured by Pacesetter Systems, it is classified as a Class III device.
What It Is
The endocardial screw-in lead model 1020t is a type of cardiac lead used in pacemaker systems. It is designed to be implanted into the heart's endocardial surface, where it delivers electrical impulses to maintain a regular heart rhythm. The screw-in mechanism ensures stable fixation to the heart tissue, reducing the risk of lead dislodgement.
FDA-Cleared Indications
- Cardiac pacing in patients with symptomatic bradycardia.
- Cardiac pacing in patients with heart block or other conduction disorders requiring pacemaker therapy.
Clinical Applications
- Permanent pacemaker implantation for patients requiring cardiac pacing.
- Endocardial ventricular or atrial lead placement, when appropriate for the prescribed pacing system and patient anatomy.
- Use with a compatible pacemaker pulse generator to deliver therapeutic electrical stimulation.
Practical Considerations
- The lead is implanted through venous access and advanced under fluoroscopic guidance to the selected cardiac chamber.
- Its active-fixation screw is deployed into the endocardial tissue to help maintain lead position; implantation requires appropriate cardiac electrophysiology technique.
- Lead length and configuration must be selected for the patient's venous route, heart anatomy and compatible pacemaker generator.
- MRI safety cannot be determined from the available FDA record. The lead should be treated as not established as MRI-conditional unless the complete system labeling confirms MRI compatibility.
- Potential complications include lead dislodgement, failure to capture or sense, venous or cardiac perforation, arrhythmia, infection and need for lead revision.
Frequently Asked Questions
What is the endocardial screw-in lead model 1020t used for?
It is used for cardiac pacing in patients with arrhythmias such as bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to conditions like slow heart rates 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.