📋 FDA Reference
Lifeline Endocardial Unipolar 487-06 Tle Lead
Intermedics
Summary: The Lifeline Endocardial Unipolar 487-06 TLE Lead is a cardiac pacing lead used in patients requiring temporary or permanent pacing. It is typically used by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K853520 ↗
Decision Date ?
October 8, 1985
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Lifeline Endocardial Unipolar 487-06 TLE Lead was cleared via the FDA 510k pathway on October 8, 1985. Manufactured by Intermedics, it is classified as a Class III medical device.
What It Is
The Lifeline Endocardial Unipolar 487-06 TLE Lead is a cardiac pacing lead designed for use in temporary or permanent cardiac pacing systems. It functions by delivering electrical impulses from a pacemaker to the heart muscle, ensuring proper heart rhythm. The unipolar design means it uses a single electrode to transmit the pacing signal, which can be beneficial in certain clinical scenarios.
FDA-Cleared Indications
- Electrical pacing of the heart in patients who require temporary or permanent cardiac pacing.
- Use as part of a compatible cardiac pacing system for patients with clinically significant bradycardia or conduction disturbances such as heart block.
Clinical Applications
- Temporary endocardial pacing in a hospital or cardiac-care setting.
- Permanent implantation as part of a compatible pacemaker system.
- Pacing support for patients with clinically significant slow heart rates.
- Pacing support for patients with atrioventricular conduction disturbances or heart block.
Practical Considerations
- The lead must be matched to a compatible pacemaker, connector, and pacing system.
- Clinicians select an appropriate lead length and position it in the heart under fluoroscopic or other imaging guidance.
- A unipolar system uses the lead tip as the active electrode and the pulse-generator casing as the return electrode; this can affect sensing, pacing thresholds, and susceptibility to electrical interference.
- MRI safety cannot be determined from the device name alone. The lead and the connected pacemaker system should be treated as not established as MRI-conditional unless current manufacturer and FDA documentation confirms otherwise.
- Use requires assessment of venous access, infection risk, cardiac anatomy, lead stability, and the patient's need for temporary versus permanent pacing.
Frequently Asked Questions
What is the Lifeline Endocardial Unipolar 487-06 TLE Lead 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 electrical pacing of the heart due to conditions like 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.