📋 FDA Reference
Tendril Unipolar Endocardial Screw-In Lead
Pacesetter
Summary: The Tendril Unipolar Endocardial Screw-In Lead is a cardiac lead used in pacemaker systems to deliver electrical impulses to the heart. It is primarily used by cardiologists in settings where cardiac pacing is required.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K951087 ↗
Decision Date ?
June 29, 1995
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Tendril Unipolar Endocardial Screw-In Lead was cleared via the FDA 510k pathway on June 29, 1995. Manufactured by Pacesetter, it is classified as a Class III medical device.
What It Is
The Tendril Unipolar Endocardial Screw-In Lead is a type of cardiac lead used in pacemaker systems. It features a screw-in mechanism that allows for secure attachment to the heart muscle, ensuring reliable delivery of electrical impulses. This lead is unipolar, meaning it has a single electrode that contacts the heart tissue, which is crucial for effective cardiac pacing.
FDA-Cleared Indications
- Use in conjunction with a compatible pacemaker system for cardiac pacing.
- Endocardial placement in the heart when electrical stimulation is needed to support cardiac rhythm.
- Use in patients whose clinical condition requires pacemaker therapy, as determined by the treating physician.
Clinical Applications
- Implantation as part of a permanent pacemaker system.
- Endocardial cardiac pacing for patients with symptomatic slow heart rhythms when pacemaker therapy is indicated.
- Placement by a cardiologist or electrophysiologist using venous access and fluoroscopic guidance.
- Connection to a compatible pulse generator to deliver pacing impulses to the heart.
Practical Considerations
- The lead is unipolar and uses a screw-in fixation mechanism; correct positioning and stable tissue contact are required for reliable pacing.
- Lead length, connector compatibility, fixation method, and electrical performance must be matched to the pulse generator and the patient's anatomy.
- MRI safety cannot be determined from the historical 1995 510(k) record alone. The complete implanted system must be evaluated under current manufacturer MRI labeling; older systems may not be MRI-conditional.
- Potential complications include lead dislodgement, failure to capture, abnormal sensing, venous injury or thrombosis, infection, perforation, and damage during removal.
- Implantation requires sterile technique, cardiac monitoring, imaging guidance, and appropriate testing of sensing, pacing thresholds, and lead impedance.
Frequently Asked Questions
What is the Tendril Unipolar Endocardial Screw-In Lead used for?
It is used for delivering electrical impulses to the heart in patients requiring cardiac pacing.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The lead is indicated for patients needing cardiac pacing due to conditions like bradycardia.
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.