MAUDE manufacturer profile
MEDTRONIC HEART VALVE, INC · NPV
MAUDE profile for Pulmonary Valve Prosthesis Percutaneously Delivered
Key facts
| Manufacturer | MEDTRONIC HEART VALVE, INC |
|---|---|
| Manufacturer group | MEDTRONIC HEART VALVES, INC |
| Product code | NPV |
| Product code name | Pulmonary Valve Prosthesis Percutaneously Delivered |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Fracture, Incomplete Coaptation, Gradient Increase, Perivalvular Leak, Device Operates Differently Than Expected, Adverse Event Without Identified Device or Use Problem, Pulmonary Regurgitation, Tricuspid Regurgitation 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