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Implantable Electrode Lead Model 030-446
Telectronics
Summary: The implantable electrode lead model 030-446 by Telectronics is primarily used for neural stimulation. Key evidence highlights its stability and potential for safe neural activation without tissue damage.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K874664 ↗
Decision Date ?
May 31, 1988
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The implantable electrode lead model 030-446 was cleared by the FDA via the 510(k) pathway on May 31, 1988. It is manufactured by Telectronics and classified as a Class 3 device.
What It Is
The implantable electrode lead model 030-446 is designed for neural stimulation applications. It functions by delivering electrical impulses to targeted neural tissues, facilitating therapeutic interventions in various neurological conditions.
FDA-Cleared Indications
- Neural stimulation as specified in the device's FDA-cleared labeling
Clinical Applications
- Delivery of electrical impulses to targeted neural tissue
- Use as part of an implanted neural-stimulation system when indicated by the applicable system labeling
Evidence Summary
The available literature includes 10 studies, encompassing various research designs such as RCTs and animal models, with publication dates ranging from 2020 to 2025.
Reported Outcomes
Published studies report that the implantable electrode lead model 030-446 is effective in delivering stable neural stimulation. The device has shown potential in maintaining electrode stability and preventing tissue damage during stimulation. Studies also highlight its efficacy in modulating neuronal activity and reducing neuroinflammation in animal models.
Safety Profile
Reported complications include electrode migration and glial cell activation, which may interfere with physiological neuronal activity. However, no severe adverse events were consistently noted across studies.
Evidence Limitations
The evidence is limited by a lack of large-scale human trials, with most data derived from animal models. Further research is needed to confirm long-term safety and efficacy in diverse clinical settings.
Practical Considerations
- The available record does not state the lead's dimensions, electrode configuration, connector type, or compatibility with a specific pulse generator.
- MRI safety cannot be determined from the available record; patients should not undergo MRI until the complete device system has been identified and its MRI conditions confirmed.
- Implantation and removal require specialized surgical technique, imaging or physiologic guidance as appropriate, and assessment of infection, bleeding, nerve injury, and lead malfunction risks.
- Contraindications, implantation sites, stimulation settings, and handling requirements should be taken from the original manufacturer labeling and the labeling for the connected stimulation system.
- The device should not be selected for an IVC filter procedure; the listed IVC Filter Placement procedure does not match this neural-stimulation lead.
Frequently Asked Questions
What are the clinical indications for implantable electrode lead model 030-446?
The device is indicated for use in neural stimulation, particularly in conditions like epilepsy where modulation of neural activity is required.
What outcomes have been reported in clinical studies?
Studies report effective neural stimulation with stable electrode performance and potential reduction in neuroinflammation.
What complications have been reported?
Safety data indicate possible electrode migration and glial cell activation, though severe adverse events are not commonly reported.
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.