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unipolar endocardial screw-in lead model 1007m
Pacesetter Systems
Summary: The unipolar endocardial screw-in lead model 1007m is a cardiac pacing lead used in permanent atrial and ventricular pacing. It is primarily used by cardiologists and electrophysiologists in cardiac care settings.
FDA Clearance Information
Pathway
510K
Number
K871208 ↗
Decision Date
June 5, 1987
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The unipolar endocardial screw-in lead model 1007m was cleared through the FDA 510(k) pathway on June 5, 1987. Manufactured by Pacesetter Systems, it is classified as a Class 2 medical device.
What It Is
The unipolar endocardial screw-in lead model 1007m is a type of cardiac pacing lead designed for permanent implantation in the heart. It features a screw-in mechanism that allows for active fixation to the endocardium, ensuring stable electrical contact for effective pacing. This device is crucial in maintaining heart rhythm in patients with bradycardia or other pacing indications.
Clinical Applications
This device is commonly used in procedures involving the implantation of pacemakers, particularly in patients requiring long-term pacing support. It is utilized in both atrial and ventricular pacing and is often employed in cardiac care units and electrophysiology labs. The primary patient population includes those with symptomatic bradycardia or atrioventricular block.
Indications for Use
The FDA indications for this device include use in patients who require permanent pacing due to conditions like bradycardia or heart block. It is suitable for individuals who need reliable long-term cardiac rhythm management.
Practical Considerations
The unipolar design means it uses a single electrode for pacing, which may influence lead placement and programming. Compatibility with specific pacemaker generators should be verified. Proper technique in screw-in fixation is essential to prevent lead dislodgement.
Related Literature
The linked study titled 'Detachment of pacemaker active fixation helix' from 1983 discusses a complication associated with active fixation leads, specifically the detachment of the helix in a Medtronic model. This highlights the importance of secure fixation in screw-in leads. However, the study's focus on a different model limits direct applicability to the 1007m lead.
Frequently Asked Questions
What is unipolar endocardial screw-in lead model 1007m used for?
It is used for permanent cardiac pacing in patients with conditions like bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists primarily use this device in cardiac care settings.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring permanent pacing due to bradycardia or atrioventricular 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.