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model sz pacemaker lead-various
Dr. Ing. P. Osypka
Summary: The model sz pacemaker lead-various by Dr. Ing. P. Osypka is a pacemaker lead cleared by the FDA for use in cardiac pacing. Key evidence includes studies on adverse outcomes in patients with atrial fibrillation and pacemakers.
FDA Clearance Information
Pathway
510K
Number
K823892 ↗
Decision Date
April 30, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on April 30, 1983. It is manufactured by Dr. Ing. P. Osypka and classified as a Class 3 device.
What It Is
The model sz pacemaker lead-various is a cardiac device component used in conjunction with pacemakers to deliver electrical impulses to the heart. It is intended for patients requiring cardiac pacing due to conditions like bradycardia or atrial fibrillation.
Clinical Applications
This device is commonly used in clinical scenarios involving patients with arrhythmias such as atrial fibrillation or sinus node dysfunction. It is particularly relevant for patients who require consistent heart rate regulation.
Evidence Summary
The available literature includes four studies, with types ranging from cohort studies to experimental research. The studies span from 2010 to 2025, providing insights into the device's clinical performance.
Reported Outcomes
Published studies report that patients with atrial fibrillation and pacemakers are at a high risk of adverse cardiovascular outcomes. Additionally, research on sinus node dysfunction highlights the role of genetic factors in heart rate regulation. The evidence suggests that pacemaker leads play a crucial role in managing these conditions.
Safety Profile
Reported complications include the potential for adverse cardiovascular outcomes in patients with atrial fibrillation using pacemakers. However, specific safety data from the studies provided is limited.
Evidence Limitations
The evidence is limited by a lack of detailed safety outcomes and specific efficacy data for the pacemaker lead itself. Further research is needed to explore long-term outcomes and device-specific complications.
Frequently Asked Questions
What are the clinical indications for model sz pacemaker lead-various?
The clinical indications are detailed in the FDA documentation, primarily involving cardiac pacing for arrhythmias such as atrial fibrillation and sinus node dysfunction.
What outcomes have been reported in clinical studies?
Studies report high risks of adverse cardiovascular outcomes in patients with atrial fibrillation and pacemakers, highlighting the importance of effective pacing.
What complications have been reported?
Safety data from the evidence indicates potential adverse cardiovascular outcomes in atrial fibrillation patients with pacemakers, though specific complications related to the lead are not detailed.
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.