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Permanent and Temp Pacemaker Electrode Lead Ada
Medtronic Vascular
Summary: The permanent and temporary pacemaker electrode lead ADA by Medtronic Vascular is a device used in cardiac pacing. It is FDA 510k cleared and primarily used for maintaining heart rhythm. Current evidence includes two studies, focusing on leadless pacemaker outcomes.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K895136 ↗
Decision Date ?
February 8, 1990
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The device was cleared through the FDA 510k pathway on February 8, 1990. It is manufactured by Medtronic Vascular and classified as a Class 3 device under product code DTB.
What It Is
The permanent and temporary pacemaker electrode lead ADA is designed for cardiac pacing, providing electrical stimulation to maintain heart rhythm. It is used in both temporary and permanent pacemaker systems.
FDA-Cleared Indications
- Cardiac pacing in patients who require electrical stimulation to maintain an adequate heart rate or rhythm.
- Temporary cardiac pacing when short-term rhythm support is needed.
- Permanent cardiac pacing when long-term rhythm support is indicated.
Clinical Applications
- Connection to a pacemaker generator for permanent cardiac pacing.
- Temporary pacing in an acute-care setting when immediate rhythm support is needed.
- Pacing support for patients with clinically significant bradycardia or heart block when a pacemaker lead is indicated.
- Delivery of electrical stimulation through a transvenous or surgically positioned cardiac pacing system, according to the applicable device labeling.
Evidence Summary
The available literature includes two studies, one from 2023, focusing on leadless pacemaker outcomes. These studies vary in design, including systematic reviews and randomized trials.
Reported Outcomes
Published studies report that leadless pacemakers, as an alternative to traditional pacemakers, have shown promising outcomes in terms of efficacy. However, consolidated data on emergency implantation scenarios is lacking.
Safety Profile
Reported complications include typical risks associated with pacemaker implantation, such as infection and lead dislodgement. Specific safety data from the provided studies is limited.
Evidence Limitations
The evidence base is limited, with a need for more comprehensive data on leadless pacemaker use in emergency settings. Further research is required to consolidate safety and efficacy findings.
Practical Considerations
- The lead must be compatible with the selected pacemaker generator and implanted according to the manufacturer’s instructions.
- Lead length, diameter, connector type, fixation method, and electrode configuration should be confirmed from the specific product labeling because these details may vary by model.
- Temporary and permanent pacing leads require careful handling to avoid insulation damage, conductor fracture, dislodgment, or loss of electrical contact.
- MRI safety cannot be determined from the device name alone. MRI eligibility depends on the exact lead model, the connected generator, the complete implanted system, and the manufacturer’s conditions for use.
- Contraindications and precautions include infection at the access or implant site, inability to obtain appropriate venous or cardiac access, and patient or anatomy-specific factors that increase the risk of bleeding, perforation, thrombosis, or lead dislodgment.
Frequently Asked Questions
What are the clinical indications for permanent and temp pacemaker electrode lead ADA?
The device is indicated for use in patients requiring cardiac pacing due to arrhythmias or heart block.
What outcomes have been reported in clinical studies?
Studies report promising outcomes for leadless pacemakers, though data on emergency use is limited.
What complications have been reported?
Safety data indicates risks such as infection and lead dislodgement, typical of pacemaker implantation.
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.