MAUDE manufacturer profile
MEDTRONIC HEART VALVES DIVISION · KRH
MAUDE profile for Ring, Annuloplasty
Key facts
| Manufacturer | MEDTRONIC HEART VALVES DIVISION |
|---|---|
| Manufacturer group | MEDTRONIC HEART VALVES DIVISION |
| Product code | KRH |
| Product code name | Ring, Annuloplasty |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 1,000+ Injury reports
- 10–99 Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- Insufficient Information, No Information, Adverse Event Without Identified Device or Use Problem, Mitral Regurgitation, Mitral Valve Insufficiency/ Regurgitation, Patient Device Interaction Problem, Non specific EKG/ECG Changes Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1