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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 ?
510(k)
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.
FDA-Cleared Indications
- Use as a lead component of a cardiac pacemaker system for electrical stimulation of the heart.
- Use in patients requiring cardiac pacing for clinically significant bradycardia or conduction disorders, when prescribed by a qualified physician.
Clinical Applications
- Connecting a pacemaker generator to the heart to provide therapeutic electrical stimulation.
- Cardiac pacing in patients with symptomatic slow heart rates or impaired cardiac conduction.
- Use during implantation or replacement of a compatible pacemaker system, according to the device labeling and physician plan.
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.
Practical Considerations
- Compatibility must be confirmed with the selected pacemaker generator, connector standard, lead configuration, and implantation approach.
- The exact lead length, diameter, fixation method, and electrode configuration depend on the specific Model SZ variant; clinicians should verify the original labeling and package information.
- MRI safety cannot be determined from the FDA record alone. Patients should not undergo MRI unless the complete implanted system is specifically labeled as MR Safe or MR Conditional and all conditions are met.
- Potential complications include lead displacement, fracture, insulation failure, abnormal electrical measurements, infection, bleeding, vascular injury, and cardiac perforation.
- The lead is intended for trained cardiac-device specialists and requires testing of sensing, pacing thresholds, and lead integrity after implantation.
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.