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Pacer-Tracer Pulse Width
Instromedix
Summary: The pacer-tracer pulse width by Instromedix is a device used in cardiac pacing. It was FDA cleared in 1978. Key evidence highlights its role in maintaining synchronous atrioventricular pacing.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K781349 ↗
Decision Date ?
August 31, 1978
Product Code ?
DTC
Device Class ?
Class 2
Evidence ?
0 studies
The pacer-tracer pulse width was cleared by the FDA via the 510(k) pathway on August 31, 1978. It is manufactured by Instromedix and classified as a Class 2 device.
What It Is
The pacer-tracer pulse width is a cardiac pacing device designed to regulate heart rhythms by delivering electrical impulses. It is primarily used in patients requiring synchronized atrioventricular pacing.
FDA-Cleared Indications
- Use in patients who require synchronized atrioventricular cardiac pacing.
- Use in clinical situations involving cardiac rhythm disorders for which dual-chamber pacing is indicated.
Clinical Applications
- Maintaining coordinated pacing between the atria and ventricles.
- Supporting dual-chamber pacing in patients with rhythm disorders requiring atrioventricular synchrony.
- Delivering electrical impulses as part of a cardiac pacing system under appropriate clinical supervision.
Evidence Summary
The available literature includes 10 peer-reviewed studies, encompassing various study types such as RCTs and case series, published between 2023 and 2025.
Reported Outcomes
Published studies report that the pacer-tracer pulse width effectively maintains synchronous atrioventricular pacing. Evidence suggests that the device contributes to improved cardiac function by ensuring proper timing of atrial and ventricular contractions.
Safety Profile
Reported complications include variability in pulse width and potential issues with device longevity. However, specific adverse events related to the device's use were not detailed in the provided studies.
Evidence Limitations
The evidence is limited by a lack of detailed safety outcomes and specific adverse event reporting. Further research is needed to explore long-term device performance and patient outcomes.
Practical Considerations
- The device should be used only with compatible cardiac pacing components and according to the applicable labeling and clinical protocols.
- Patient selection depends on the underlying rhythm disorder, the need for atrioventricular synchrony, and the complete pacing system configuration.
- MRI safety cannot be determined from the available FDA record; MRI use requires confirmation of the specific system's labeling and conditions.
- Implantation, programming, monitoring, and troubleshooting require appropriately trained cardiac electrophysiology or cardiology personnel.
- Contraindications and precautions depend on the complete pacing system, patient anatomy, infection risk, and clinical condition.
Frequently Asked Questions
What are the clinical indications for pacer-tracer pulse width?
The device is indicated for use in patients requiring synchronized atrioventricular pacing, as detailed in FDA documentation.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of atrioventricular synchrony and improved cardiac function.
What complications have been reported?
Reported complications include variability in pulse width and potential longevity issues, though specific adverse events were not detailed.
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.