📋 FDA Reference
Pacing Models Mum 860 Mum 890
R.E. Brown
Summary: The Pacing Models MUM 860 and MUM 890 are cardiac pacing devices used to manage heart rhythm disorders. They are primarily used by cardiologists in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K781623 ↗
Decision Date ?
December 8, 1978
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Pacing Models MUM 860 and MUM 890, manufactured by R.E. Brown, were cleared by the FDA under 510k K781623 on December 8, 1978. They are classified as Class III devices.
What It Is
These devices are cardiac pacemakers designed to regulate heartbeats in patients with arrhythmias. They deliver electrical impulses to the heart muscles to maintain an adequate heart rate, especially in conditions where the heart's natural pacemaker is faulty. The devices are implanted under the skin and connected to the heart through leads.
FDA-Cleared Indications
- Treatment of symptomatic bradycardia requiring cardiac pacing.
- Treatment of heart block requiring cardiac pacing.
- Treatment of cardiac rhythm disorders associated with an inadequate heart rate.
Clinical Applications
- Long-term pacing support for adults with symptomatic slow heart rates.
- Pacing for patients with heart block that causes an inadequate ventricular rate.
- Implantation in a hospital cardiology or electrophysiology setting when the heart's natural pacemaker is not functioning adequately.
Practical Considerations
- Confirm that the generator is compatible with the selected or existing pacing leads before implantation or replacement.
- Implantation requires appropriate surgical technique, lead positioning, device testing and postoperative monitoring.
- The record does not provide device-specific MRI-conditional labeling; MRI safety should be confirmed from the original labeling and the complete implanted system before scanning.
- Assess for infection, bleeding risk, venous access limitations and other patient-specific contraindications to pacemaker implantation.
- The available record does not specify generator dimensions, lead configurations, battery longevity or replacement intervals; verify these details in the original manufacturer documentation.
Frequently Asked Questions
What is Pacing Models MUM 860 MUM 890 used for?
These devices are used to regulate heartbeats in patients with arrhythmias, particularly those with slow heart rates or heart block.
What specialties typically use this device?
These pacemakers are primarily used by cardiologists, especially those specializing in electrophysiology.
What are the FDA-cleared indications?
The devices are indicated for patients with symptomatic bradycardia or heart block requiring pacing support.
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.