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Oscor Medical Implantable Pacing Lead Retractable
Oscor Medical
Summary: The Oscor Medical implantable pacing lead is a device used in cardiac pacing. It is primarily used for maintaining heart rhythm in patients with arrhythmias. Key evidence highlights issues with spurious signals causing pacemaker inhibition.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K850623 ↗
Decision Date ?
April 19, 1985
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Oscor Medical implantable pacing lead was cleared by the FDA through the 510(k) pathway on April 19, 1985. It is manufactured by Oscor Medical and classified as a Class 3 device.
What It Is
The Oscor Medical implantable pacing lead is designed to deliver electrical impulses to the heart to maintain an appropriate heart rate in patients with arrhythmias. It features a retractable mechanism for secure placement within cardiac tissue.
FDA-Cleared Indications
- Use as an implantable cardiac pacing lead when electrical stimulation of the heart is indicated.
- Use with a compatible pacemaker system for patients requiring temporary or long-term cardiac pacing, according to the device labeling.
Clinical Applications
- Placement in the heart as part of an implantable pacemaker system.
- Delivery of pacing impulses to cardiac tissue in patients with clinically significant bradycardia.
- Cardiac pacing for patients with conduction disorders such as heart block when pacing is indicated.
- Retractable fixation of the lead within cardiac tissue during pacemaker implantation.
Evidence Summary
The available literature includes two studies from 1990, focusing on the device's performance and complications. These studies are case series and retrospective analyses, providing insights into device-related issues.
Reported Outcomes
Published studies report that the Oscor Medical pacing lead can cause false inhibition of pacemaker output due to spurious signals. Reprogramming the sensing channel to unipolar ring has been shown to prevent this issue.
Safety Profile
Reported complications include false inhibition of ventricular output due to spurious signals from the lead. These signals were identified as originating from the distal screw-in electrode.
Evidence Limitations
The evidence is limited to older studies with small sample sizes and lacks recent data. Further research is needed to evaluate long-term outcomes and safety in diverse patient populations.
Practical Considerations
- The retractable fixation mechanism must be handled according to the manufacturer's instructions to avoid lead damage or inadequate fixation.
- Compatibility with the implanted pulse generator, connectors, pacing mode and other system components must be confirmed before implantation.
- The available lead length, diameter and configuration should be matched to the patient's anatomy and the planned venous access route.
- MRI safety cannot be assumed for this lead or for a pacemaker system containing it; the complete implanted system must be evaluated against current MRI-conditional labeling.
- Potential complications include lead dislodgement, failure to capture, abnormal sensing, infection, vascular or cardiac injury, and pacemaker inhibition from spurious signals.
Frequently Asked Questions
What are the clinical indications for Oscor Medical implantable pacing lead?
The device is indicated for patients requiring cardiac pacing due to arrhythmias such as bradycardia or heart block.
What outcomes have been reported in clinical studies?
Studies have reported issues with spurious signals causing pacemaker inhibition, which can be mitigated by reprogramming the sensing channel.
What complications have been reported?
Safety data indicates complications such as false inhibition of pacemaker output due to spurious signals from the lead.
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.