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pacemaker perm temp electrode
Daig
Summary: The pacemaker perm temp electrode by Daig is a device used in cardiac pacing, primarily for temporary pacing needs. It is utilized by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K772197 ↗
Decision Date
January 30, 1978
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510k pathway on January 30, 1978, and is manufactured by Daig. It is classified as a Class 3 device under the product code DTB.
What It Is
The pacemaker perm temp electrode is a medical device used for temporary cardiac pacing. It functions by delivering electrical impulses to the heart muscle to maintain an adequate heart rate, especially in cases of bradycardia or heart block. The electrode is typically inserted transvenously and connected to an external pacemaker generator.
Clinical Applications
This device is commonly used in acute care settings such as intensive care units and operating rooms. It is particularly useful in managing patients with acute heart block or bradycardia following cardiac surgery or myocardial infarction. Cardiologists and electrophysiologists are the primary users, often employing it in emergency situations or when permanent pacing is not immediately feasible.
Indications for Use
The pacemaker perm temp electrode is indicated for patients requiring temporary cardiac pacing. This includes individuals experiencing transient heart block, bradycardia, or other conditions where temporary pacing support is necessary.
Practical Considerations
When using this device, clinicians should consider the appropriate size and compatibility with the external pacemaker generator. Proper insertion technique is crucial to avoid complications such as infection or lead dislodgement.
Related Literature
The linked study reviewed outcomes of primary leadless pacemaker implantation, highlighting the growing preference for leadless systems over traditional transvenous pacemakers. While the study provides valuable insights into the efficacy and safety of leadless pacemakers, it notes a lack of consolidated data on their use in emergency settings, suggesting a need for further research in this area.
Frequently Asked Questions
What is the pacemaker perm temp electrode used for?
It is used for temporary cardiac pacing in patients with conditions like heart block or bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists commonly use this device, especially in acute care settings.
What are the FDA-cleared indications?
The device is indicated for temporary pacing in patients with transient heart block or bradycardia.
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.