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monitor pacemaker
Adcor Electronics
Summary: The monitor pacemaker by Adcor Electronics is a device used to monitor and regulate heart rhythms. It is primarily used in patients with arrhythmias. Key evidence highlights its efficacy in detecting pacemaker pulses even at low sampling frequencies.
FDA Clearance Information
Pathway 510K
Number K770865 ↗
Decision Date June 14, 1977
Product Code DTC
Device Class Class 2
Evidence 0 studies
The monitor pacemaker was cleared through the FDA 510(k) pathway on June 14, 1977. It is manufactured by Adcor Electronics and classified as a Class 2 device under product code DTC.
What It Is
The monitor pacemaker is a medical device designed to monitor and regulate cardiac rhythms. It is used in clinical settings to assess pacemaker function and ensure proper cardiac pacing in patients with arrhythmias.
Clinical Applications
This device is commonly used in patients with arrhythmias, including atrial fibrillation and AV blocks. It provides clinicians with real-time data on pacemaker performance and assists in diagnosing and managing cardiac rhythm disorders.
Evidence Summary
The available literature includes 15 studies, ranging from 2002 to 2021, encompassing various study types such as RCTs, prospective, and retrospective studies. These studies focus on the efficacy and safety of pacemaker monitoring in different clinical scenarios.
Reported Outcomes
Published studies report that the monitor pacemaker is effective in detecting pacemaker pulses at low sampling frequencies, which is crucial for accurate assessment of pacemaker function. It has been shown to be beneficial in managing patients with complex arrhythmias, contributing to improved clinical outcomes.
Safety Profile
Reported complications include potential issues with pulse detection accuracy at very low amplitudes or durations. However, no significant adverse events have been consistently documented across the studies.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale, long-term studies. Further research is needed to explore the device's performance in diverse patient populations and its long-term impact on clinical outcomes.
Frequently Asked Questions
What are the clinical indications for monitor pacemaker?
The monitor pacemaker is indicated for use in patients with arrhythmias, including atrial fibrillation and AV blocks, to monitor and regulate cardiac rhythms.
What outcomes have been reported in clinical studies?
Studies have reported effective detection of pacemaker pulses and improved management of arrhythmias, contributing to better clinical outcomes.
What complications have been reported?
Safety data indicate potential issues with pulse detection accuracy, but no significant adverse events have been consistently reported.
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.