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temporary pacemaker ground wire
Scholten Surgical Instruments
Summary: The temporary pacemaker ground wire by Scholten Surgical Instruments is used to provide temporary cardiac pacing during procedures that may induce bradycardia. It is typically used by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K852119 ↗
Decision Date
September 15, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The temporary pacemaker ground wire was cleared through the FDA 510k pathway on September 15, 1985. It is manufactured by Scholten Surgical Instruments and classified as a Class III device.
What It Is
The temporary pacemaker ground wire is a medical device used to provide temporary cardiac pacing. It functions by connecting to a temporary pacemaker to stabilize heart rhythms during procedures that may cause bradycardia or heart block. This device is crucial in maintaining adequate cardiac output and preventing hemodynamic instability in patients undergoing certain cardiac interventions.
Clinical Applications
This device is commonly used in interventional cardiology, particularly during procedures like rotational atherectomy where there is a risk of inducing bradycardia. It is utilized in settings such as catheterization labs and cardiac surgery suites. The primary patient population includes those undergoing complex coronary interventions, especially those with calcified lesions.
Indications for Use
The FDA indications suggest this device is for patients at risk of bradycardia during cardiac procedures. It is particularly useful in procedures where temporary pacing might be needed to manage heart rhythm disturbances.
Practical Considerations
The device is compatible with standard temporary pacemakers and is typically used with pacing catheters. Clinicians should ensure proper connection and secure placement to prevent dislodgement during procedures.
Related Literature
The linked study explored the use of a Rota wire for trans-coronary pacing to prevent bradycardia during rotational atherectomy. It highlighted the effectiveness of this approach in a case involving the proximal right coronary artery. While promising, the study is limited by its single-case design and may not be generalizable.
Frequently Asked Questions
What is the temporary pacemaker ground wire used for?
It is used to provide temporary cardiac pacing during procedures that may cause bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists commonly use this device, especially in interventional cardiology settings.
What are the FDA-cleared indications?
The device is indicated for use in patients at risk of bradycardia during cardiac procedures, particularly those involving coronary interventions.
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.