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permanent temp pacemaker electrode
Daig
Summary: The permanent temp pacemaker electrode by Daig is a device used for cardiac pacing. It is primarily used in patients requiring temporary pacing. Key evidence includes studies on leadless pacemakers, though specific data on this device is limited.
FDA Clearance Information
Pathway
510K
Number
K800795 ↗
Decision Date
June 30, 1980
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared by the FDA through the 510(k) pathway on June 30, 1980. It is manufactured by Daig and classified as a Class 3 device.
What It Is
The permanent temp pacemaker electrode is designed for temporary cardiac pacing. It functions by delivering electrical impulses to stimulate heart contractions, used in scenarios where temporary pacing is required.
Clinical Applications
Commonly used in situations requiring temporary cardiac pacing, such as during cardiac surgery or in cases of bradycardia. It provides a temporary solution until a permanent pacemaker can be implanted if necessary.
Evidence Summary
The available literature includes two studies, one from 2023 and another with an unknown date. The studies include a systematic review and a randomized trial, focusing on leadless pacemakers and related technologies.
Reported Outcomes
Published studies report on the outcomes of leadless pacemaker implantation, highlighting their increasing use as an alternative to traditional pacemakers. However, specific outcomes related to the permanent temp pacemaker electrode are not detailed in the provided studies.
Safety Profile
Reported complications include general risks associated with pacemaker implantation, such as infection and lead dislodgement. Specific safety data for the permanent temp pacemaker electrode is not detailed in the provided studies.
Evidence Limitations
The evidence is limited by a lack of specific studies on the permanent temp pacemaker electrode. Further research is needed to evaluate its efficacy and safety in various clinical settings.
Frequently Asked Questions
What are the clinical indications for permanent temp pacemaker electrode?
The device is indicated for temporary cardiac pacing in situations such as bradycardia or during cardiac surgery.
What outcomes have been reported in clinical studies?
Studies focus on leadless pacemakers, reporting their effectiveness as alternatives to traditional pacemakers, but specific outcomes for this device are not detailed.
What complications have been reported?
Safety data from the evidence includes general risks like infection and lead dislodgement, though specific complications for this device 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.