MAUDE manufacturer profile
MEDTRONIC CARDIOVASCULAR SANTA ROSA · MIH
MAUDE profile for System, Endovascular Graft, Aortic Aneurysm Treatment
Key facts
| Manufacturer | MEDTRONIC CARDIOVASCULAR SANTA ROSA |
|---|---|
| Manufacturer group | MEDTRONIC CARDIOVASCULAR SANTA ROSA |
| Product code | MIH |
| Product code name | System, Endovascular Graft, Aortic Aneurysm Treatment |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 1,000+ Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Leak/Splash, Injury, Migration or Expulsion of Device, No Consequences Or Impact To Patient, Adverse Event Without Identified Device or Use Problem, Rupture, Occlusion, Pain 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