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medtronic 5311 pacing system analyzer
Medtronic Vascular
Summary: The Medtronic 5311 Pacing System Analyzer is a device used for assessing pacing system parameters. It is primarily used in cardiac pacing procedures. Key evidence highlights its role in measuring pacing impedance and potential idiosyncratic responses during use.
FDA Clearance Information
Pathway 510K
Number K850077 ↗
Decision Date July 16, 1985
Product Code DTC
Device Class Class 2
Evidence 0 studies
The Medtronic 5311 Pacing System Analyzer was cleared by the FDA via the 510(k) pathway on July 16, 1985. It is manufactured by Medtronic Vascular and classified as a Class 2 device.
What It Is
The Medtronic 5311 Pacing System Analyzer is designed to evaluate pacing system parameters such as impedance, output, and current. It is intended for use in cardiac pacing procedures to ensure proper device function and patient safety.
Clinical Applications
This device is commonly used in scenarios involving the implantation and assessment of cardiac pacing systems. It provides clinicians with critical data on pacing system performance, aiding in the management of patients requiring cardiac pacing.
Evidence Summary
The available literature includes three studies ranging from 1993 to 2007. These studies encompass various methodologies, including case series and observational analyses, focusing on the device's performance and clinical implications.
Reported Outcomes
Published studies report that the Medtronic 5311 Pacing System Analyzer is effective in measuring pacing impedance and other parameters. It has been used to assess the dynamics of pacemaker lead implantation and the response of pacing systems under different conditions.
Safety Profile
Reported complications include idiosyncratic responses during high output AAI pacing, particularly when using mismatched cables and adaptors. No significant adverse events were noted in the studies reviewed.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of recent research. Further studies are needed to explore long-term outcomes and potential complications in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Medtronic 5311 Pacing System Analyzer?
The device is indicated for use in assessing pacing system parameters during cardiac pacing procedures, as per FDA documentation.
What outcomes have been reported in clinical studies?
Studies report effective measurement of pacing impedance and other parameters, with observations on implant dynamics and system responses.
What complications have been reported?
Safety data indicate potential idiosyncratic responses during high output AAI pacing, especially with mismatched cables and adaptors.
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.