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pacemaker electrode permanent temp
Daig
Summary: The pacemaker electrode permanent temp by Daig is a device used in cardiac pacing. It is primarily indicated for patients requiring permanent pacing. Key evidence includes a systematic review of leadless pacemakers.
FDA Clearance Information
Pathway
510K
Number
K780246 ↗
Decision Date
August 31, 1978
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The pacemaker electrode permanent temp was cleared by the FDA through the 510k pathway on August 31, 1978. It is manufactured by Daig and classified as a Class 3 device.
What It Is
The pacemaker electrode permanent temp is a cardiac device designed to provide electrical stimulation to the heart muscle, ensuring adequate heart rate and rhythm. It is intended for patients who require permanent cardiac pacing.
Clinical Applications
This device is commonly used in scenarios where patients have bradycardia or other conditions necessitating permanent pacing. It is typically implanted in patients who have not responded to medication or other treatments.
Evidence Summary
The available literature includes a systematic review of leadless pacemakers, highlighting their use as an alternative to traditional pacemakers. The studies span recent years, with a focus on outcomes and safety.
Reported Outcomes
Published studies report that leadless pacemakers, such as the one reviewed, have become a prevalent alternative to traditional pacemakers. However, there is limited consolidated data on their use in emergency situations.
Safety Profile
Reported complications include the lack of comprehensive data on the safety of leadless pacemakers in emergency settings. Further research is needed to establish a robust safety profile.
Evidence Limitations
The evidence is limited by the lack of consolidated data on emergency use and the relatively recent adoption of leadless technology. Further studies are needed to explore long-term outcomes and safety.
Frequently Asked Questions
What are the clinical indications for pacemaker electrode permanent temp?
The device is indicated for patients requiring permanent cardiac pacing, as detailed in FDA documentation.
What outcomes have been reported in clinical studies?
Studies report that leadless pacemakers are a viable alternative to traditional devices, though data on emergency use is limited.
What complications have been reported?
Safety data indicates a need for more research on emergency use, with no specific adverse events detailed in the provided evidence.
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.