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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 ?
510(k)
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.
FDA-Cleared Indications
- Evaluation of cardiac pacing-system electrical parameters, including impedance, output, and current.
- Testing and assessment of pacing leads and connected pacing-system components during cardiac pacing procedures.
Clinical Applications
- Measuring pacing-lead impedance during pacemaker implantation or system evaluation.
- Assessing pacing output and current to help verify cardiac pacing-system performance.
- Testing pacing-system components during implantation, revision, or troubleshooting.
- Supporting intraoperative evaluation of cardiac pacing systems under the direction of qualified cardiac pacing clinicians.
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.
Practical Considerations
- This is an external testing and measurement device, not an implanted pacemaker or pacing lead.
- Use requires compatibility with the pacing leads, connectors, cables, and other equipment used in the procedure; staff should verify the applicable technical documentation before connection.
- Measurements should be interpreted by qualified clinicians because values can be affected by lead position, tissue contact, connection quality, pacing settings, and the test environment.
- The device is not an MRI system or an implanted MRI-conditional component. MRI decisions apply to the patient's implanted pacing system and should follow the complete system's labeling and institutional protocol.
- The record identifies a Class II device cleared through the 510(k) pathway under product code DTC; current availability, accessories, servicing, and compatibility may require confirmation with the manufacturer or facility biomedical department.
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.