đź“‹ FDA Reference
afp cardiac pacing system model 283
Siemens-Pacesetter
Summary: The AFP Cardiac Pacing System Model 283 is a dual-chamber pacemaker used to manage arrhythmias. It is primarily used by cardiologists for patients with heart rhythm disorders.
FDA Clearance Information
Pathway
510K
Number
K942440 ↗
Decision Date
August 8, 1994
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The AFP Cardiac Pacing System Model 283, manufactured by Siemens-Pacesetter, was cleared through the FDA 510k pathway on August 8, 1994. It is a Class III medical device.
What It Is
The AFP Cardiac Pacing System Model 283 is a dual-chamber pacemaker designed to regulate heart rhythms by delivering electrical impulses to the heart. It features both atrial and ventricular leads, allowing for atrioventricular sequential pacing. This system helps maintain appropriate heart rates in patients with bradycardia or other arrhythmias.
Clinical Applications
This device is commonly used in cardiology for patients with atrioventricular block, sick sinus syndrome, or other conditions causing slow heart rates. It is typically implanted in a hospital setting by electrophysiologists or cardiologists. The device is suitable for adult patients who require pacing support to maintain adequate cardiac output.
Indications for Use
The AFP Cardiac Pacing System Model 283 is indicated for patients who experience slow heart rhythms due to conditions like heart block or sinus node dysfunction. It helps ensure the heart beats at a normal rate.
Practical Considerations
The device is compatible with both unipolar and bipolar leads, providing flexibility in implantation techniques. It is important to consider the patient's size and anatomy when selecting lead placement to ensure optimal device performance.
Related Literature
The linked study investigated myopotential interference in DDD-mode pacemakers, including the AFP models 281 and 283. It found that skeletal muscle activity could affect pacemaker function, leading to arrhythmias in some patients. The study highlighted the importance of monitoring for myopotential interference but was limited by a small sample size.
Frequently Asked Questions
What is the AFP Cardiac Pacing System Model 283 used for?
It is used to manage arrhythmias by providing electrical pacing to the heart, particularly in patients with slow heart rhythms.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for patients with conditions like heart block or sinus node dysfunction that cause slow heart rhythms.
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.