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pacemaker electrode perm temp
Daig
Summary: The pacemaker electrode perm temp by Daig is a device used in cardiac pacing, primarily by cardiologists. It is essential for patients requiring temporary or permanent heart rhythm management.
FDA Clearance Information
Pathway
510K
Number
K830464 ↗
Decision Date
March 16, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510k pathway on March 16, 1983. Manufactured by Daig, it is classified as a Class 3 device, indicating a higher risk level requiring stringent regulatory controls.
What It Is
The pacemaker electrode perm temp is a medical device designed to deliver electrical impulses to the heart muscle to maintain an adequate heart rate and rhythm. It is typically used in conjunction with a pacemaker generator. The electrode is implanted into the heart tissue, where it helps regulate cardiac function by providing necessary electrical stimulation.
Clinical Applications
This device is commonly used in cardiology, particularly in settings where patients require temporary or permanent pacing support. It is often utilized in acute care settings such as hospitals, especially in emergency situations or during surgical procedures where heart rhythm management is critical. The device is suitable for patients with bradycardia or other arrhythmias requiring pacing intervention.
Indications for Use
The FDA indications suggest this device is intended for patients who need temporary or permanent cardiac pacing. It is particularly useful in managing conditions like bradycardia, where the heart beats too slowly, or in cases where the heart's electrical conduction system is impaired.
Practical Considerations
Clinicians should consider the compatibility of the electrode with the pacemaker generator being used. Proper sizing and placement technique are crucial to ensure effective pacing and minimize complications. Familiarity with the device's handling and insertion is essential for optimal outcomes.
Related Literature
The linked study reviews outcomes of leadless pacemaker implantation, highlighting its growing use as an alternative to traditional pacemakers. Key findings suggest that leadless pacemakers offer benefits in reducing infection risks and lead-related complications. However, the study notes a lack of consolidated data on their use in emergency settings, indicating a need for further research in this area.
Frequently Asked Questions
What is the pacemaker electrode perm temp used for?
It is used for delivering electrical impulses to the heart to maintain proper heart rhythm, especially in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists primarily use this device in both acute and chronic care settings.
What are the FDA-cleared indications?
The device is indicated for patients needing temporary or permanent cardiac pacing, such as those with bradycardia or impaired electrical conduction in the heart.
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.