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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
510K
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.
Clinical Applications
This device is commonly used in patients requiring cardiac pacing due to conditions such as bradycardia or heart block. It is typically implanted in scenarios where long-term pacing is necessary.
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.
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.