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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 FDA-cleared and primarily used in scenarios requiring temporary pacing. Key evidence includes a systematic review of leadless pacemakers.
FDA Clearance Information
Pathway
510K
Number
K802547 ↗
Decision Date
January 16, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The permanent temp pacemaker electrode was cleared by the FDA through the 510k pathway on January 16, 1981. 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, typically used in acute settings where temporary pacing is required.
Clinical Applications
This device is commonly used in clinical scenarios such as bradycardia management, during cardiac surgery, or in emergency settings where temporary pacing is necessary to maintain adequate heart rate and rhythm.
Evidence Summary
The available literature includes a systematic review and a clinical trial, focusing on leadless pacemakers and related technologies. The studies span recent years, though specific patient numbers and detailed outcomes are limited.
Reported Outcomes
Published studies report that leadless pacemakers, as alternatives to traditional pacemakers, show promising outcomes in terms of implantation success and patient satisfaction. However, specific outcomes related to the permanent temp pacemaker electrode are not detailed in the provided evidence.
Safety Profile
Reported complications include general risks associated with pacemaker implantation, such as infection and lead dislodgement. The provided studies do not specify safety data for the permanent temp pacemaker electrode.
Evidence Limitations
The evidence is limited by a lack of specific data on the permanent temp pacemaker electrode itself, with most studies focusing on leadless pacemakers. Further research is needed to directly assess the efficacy and safety of this specific device.
Frequently Asked Questions
What are the clinical indications for permanent temp pacemaker electrode?
The clinical indications are detailed in the FDA documentation, typically involving scenarios requiring temporary cardiac pacing.
What outcomes have been reported in clinical studies?
The systematic review highlights successful implantation and patient satisfaction with leadless 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 data for this device is not provided.
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.