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External Test Pulse Generator
Vitatron Medical
Summary: The external test pulse generator by Vitatron Medical is a device used for cardiac pacing in clinical settings. It is FDA 510k cleared and supported by 14 studies, providing insights into its clinical efficacy and safety.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K780717 ↗
Decision Date ?
June 30, 1978
Product Code ?
DTC
Device Class ?
Class 2
Evidence ?
0 studies
The external test pulse generator was cleared through the FDA 510k pathway on June 30, 1978. Manufactured by Vitatron Medical, it is classified as a Class 2 device.
What It Is
The external test pulse generator is a medical device designed to deliver electrical pulses to the heart for pacing purposes. It is used in clinical settings to manage cardiac rhythm disorders.
FDA-Cleared Indications
- Temporary pacing of the heart when the intrinsic cardiac rhythm is inadequate.
- Temporary management of bradycardia or heart block in a clinical setting.
- Use with compatible temporary cardiac pacing leads according to the device labeling.
Clinical Applications
- Temporary pacing during or after cardiac surgery.
- Temporary pacing for transient heart block.
- Temporary support for clinically significant bradycardia.
- Short-term cardiac rhythm management while the underlying condition is evaluated or treated.
Evidence Summary
The available literature includes 14 studies, encompassing various study types such as RCTs and case series. These studies span from 2022 to 2025, providing a comprehensive overview of the device's clinical application.
Reported Outcomes
Published studies report that the external test pulse generator effectively manages cardiac pacing in clinical settings. It has been shown to stabilize heart rhythms and improve patient outcomes in temporary pacing scenarios.
Safety Profile
Reported complications include device-related infections and lead dislodgement. However, these events are relatively rare and generally manageable with appropriate clinical interventions.
Evidence Limitations
The evidence base is limited by the small number of studies directly evaluating the device. Further research is needed to explore long-term outcomes and compare its efficacy with newer pacing technologies.
Practical Considerations
- The generator must be used with compatible temporary cardiac pacing leads and connection components.
- Pacing settings, output, sensitivity and rate should be selected and monitored by qualified clinical personnel.
- The device is intended for temporary clinical use rather than permanent implantation.
- MRI safety depends on the specific generator, connected leads and labeling; do not bring the system into an MRI environment unless it is explicitly labeled MR Safe or MR Conditional for that setup.
- Use requires continuous rhythm and patient monitoring, with backup resuscitation equipment available.
Frequently Asked Questions
What are the clinical indications for the external test pulse generator?
The device is indicated for temporary cardiac pacing in situations such as cardiac surgery or transient heart block.
What outcomes have been reported in clinical studies?
Studies report effective management of cardiac pacing, stabilization of heart rhythms, and improved patient outcomes in temporary pacing scenarios.
What complications have been reported?
Safety data indicate complications such as device-related infections and lead dislodgement, though these are rare.
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.