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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 ?
510(k)
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.
FDA-Cleared Indications
- Temporary cardiac pacing when the heart rate or rhythm is inadequate.
- Temporary pacing support during acute cardiac care or procedures when indicated by the treating physician.
Clinical Applications
- Temporary pacing for clinically significant bradycardia.
- Temporary cardiac pacing during or after cardiac procedures when short-term pacing support is required.
- Emergency temporary pacing when an unstable heart rhythm requires electrical support.
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.
Practical Considerations
- The electrode is used with compatible temporary pacing equipment; connector and generator compatibility must be confirmed before use.
- Placement requires sterile technique and cardiac monitoring, with positioning confirmed according to the device labeling and clinical practice.
- Potential complications include bleeding, infection, vascular or cardiac injury, arrhythmia, lead displacement, and loss of capture.
- MRI safety cannot be assumed from the available FDA record; the electrode and the complete pacing system should be evaluated before MRI.
- The device is intended for temporary use, not permanent implantation. Duration depends on the clinical situation, lead performance, and the treating team's plan.
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.