📋 FDA Reference
Endocardial Screw-In Lead Model 1028t
Pacesetter Systems
Summary: The endocardial screw-in lead model 1028t is a cardiac device used for pacing the heart. It is typically used by cardiologists in patients requiring pacemaker therapy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K902147 ↗
Decision Date ?
July 17, 1990
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The endocardial screw-in lead model 1028t was cleared via the FDA 510k pathway on July 17, 1990. Manufactured by Pacesetter Systems, it is classified as a Class III device.
What It Is
The endocardial screw-in lead model 1028t is a type of cardiac lead designed to be implanted in the heart's endocardium. It functions by delivering electrical impulses to stimulate heart contractions, essential for patients with bradycardia or heart block. The screw-in mechanism ensures stable attachment to the heart tissue, improving lead performance and patient outcomes.
FDA-Cleared Indications
- Use as an endocardial pacing lead in patients requiring permanent cardiac pacing.
- Use to deliver electrical stimulation from a pacemaker generator to the heart.
- Use when stable attachment of the pacing electrode to endocardial heart tissue is required.
Clinical Applications
- Permanent pacemaker implantation for patients with symptomatic bradycardia.
- Pacing therapy for patients with atrioventricular or other cardiac conduction block.
- Placement of an active-fixation lead against the endocardium as part of a pacemaker system.
- Connection to a compatible pacemaker pulse generator to deliver cardiac pacing impulses.
Practical Considerations
- The lead is implanted through the venous system and positioned inside a cardiac chamber under fluoroscopic guidance.
- The active-fixation screw must be deployed and tested for stable attachment, pacing threshold, sensing, and acceptable impedance.
- Compatibility with the pacemaker generator, connector configuration, lead length, and electrical specifications must be confirmed before implantation.
- MRI safety cannot be determined from the historical 510(k) record alone; do not assume the lead is MRI-conditional. Review the current manufacturer labeling and the complete implanted system.
- Potential complications include lead dislodgement, loss of capture or sensing, venous injury, infection, cardiac perforation, pericardial effusion, arrhythmia, and pneumothorax.
Frequently Asked Questions
What is the endocardial screw-in lead model 1028t used for?
It is used for cardiac pacing in patients with conditions like 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?
It is indicated for patients requiring electrical stimulation of the heart due to 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.