MAUDE manufacturer profile
MEDTRONIC MEXICO · LWR
MAUDE profile for Heart-Valve, Non-Allograft Tissue
Key facts
| Manufacturer | MEDTRONIC MEXICO |
|---|---|
| Manufacturer group | MEDTRONIC MEXICO |
| Product code | LWR |
| Product code name | Heart-Valve, Non-Allograft Tissue |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Insufficient Information, Patient Device Interaction Problem, Intravalvular regurgitation, Aortic Valve Insufficiency/ Regurgitation, Device Stenosis, Aortic Valve Stenosis, Gradient Increase 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