📋 FDA Reference
Passive Plus Endocardial Pacing Leads Var Models
Siemens-Pacesetter
Summary: The Passive Plus Endocardial Pacing Leads are used in cardiac pacing procedures to help regulate heart rhythms. They are primarily used by cardiologists in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K932892 ↗
Decision Date ?
July 6, 1994
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Passive Plus Endocardial Pacing Leads by Siemens-Pacesetter were cleared through the FDA 510k pathway on July 6, 1994. It is a Class 3 medical device.
What It Is
The Passive Plus Endocardial Pacing Leads are implantable devices designed to deliver electrical impulses to the heart muscle to maintain an adequate heart rate. These leads are placed within the heart's endocardial surface and are connected to a pacemaker. They are critical in managing arrhythmias and ensuring proper cardiac function.
FDA-Cleared Indications
- Use in patients who require electrical stimulation of the heart to maintain an adequate heart rate.
- Use with a compatible pacemaker system for endocardial cardiac pacing.
- Use in patients with bradycardia or conduction disorders requiring pacing support, as determined by the treating physician.
Clinical Applications
- Transvenous endocardial pacing for symptomatic bradycardia.
- Pacing support for patients with heart block or other cardiac conduction disorders.
- Connection of an implanted pacemaker generator to the endocardial surface of the heart.
- Long-term cardiac pacing when the treating cardiologist determines that an implanted lead is appropriate.
Practical Considerations
- The lead is implanted through a venous access site and positioned inside a heart chamber under fluoroscopic or other imaging guidance.
- Lead length and configuration should be selected for the patient's anatomy and the planned pacing system.
- Compatibility with the pacemaker generator and connector system must be confirmed before implantation; connector details should be verified in the current device documentation rather than assumed.
- MRI safety depends on the complete implanted system, including the lead, pulse generator, and programmed conditions. Do not assume an implanted system is MRI-conditional without manufacturer-specific documentation.
- Potential complications include lead dislodgement, failure to capture or sense, infection, venous thrombosis, perforation, arrhythmia, and the need for revision or replacement.
Related Literature
The linked study evaluated the safety and electrical performance of INVICTA Leads Models equipped with a DF4 connector. Although the abstract is not available, such studies typically assess the reliability of electrical connections and the lead's performance over time. Limitations might include a lack of long-term data or a small sample size.
Frequently Asked Questions
What is Passive Plus Endocardial Pacing Leads used for?
They are used to deliver electrical impulses to the heart to maintain a regular heartbeat in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists in hospital settings use this device.
What are the FDA-cleared indications?
The device is indicated for patients needing electrical stimulation of the heart to maintain a regular heartbeat, such as those with 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.