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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 ?
510(k)
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.
FDA-Cleared Indications
- Permanent atrial pacing when indicated for management of bradyarrhythmias.
- Permanent ventricular pacing when indicated for management of bradyarrhythmias or heart block.
- Use as an endocardial pacing lead with a compatible permanent pacemaker system.
Clinical Applications
- Permanent atrial pacing in patients who require long-term rhythm support.
- Permanent ventricular pacing in patients with symptomatic bradycardia.
- Ventricular pacing for selected patients with atrioventricular block or other conduction disorders.
- Active fixation of the lead to the endocardium using its screw-in mechanism during pacemaker implantation.
Practical Considerations
- The lead is unipolar, so it uses the lead tip and the pacemaker generator case as the pacing circuit; programming and sensing characteristics differ from bipolar systems.
- It is an active-fixation lead that requires careful screw deployment and testing to reduce the risk of dislodgement or inadequate electrical contact.
- Compatibility with the pacemaker generator, connector standard, lead length, and pacing system must be confirmed before implantation.
- MRI safety cannot be assumed. This older lead and the complete implanted pacemaker system should be evaluated against current MRI-conditional labeling; many legacy systems are not MRI-conditional.
- Lead size, length, insertion technique, and acceptable electrical parameters should be verified in the manufacturer’s original instructions for use. Contraindications and precautions include infection at the implant site, unsuitable venous access, and inability to safely position the lead.
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.