MAUDE manufacturer profile
MEDTRONIC HEART VALVE DIVISION · LWQ
MAUDE profile for Heart-Valve, Mechanical
Key facts
| Manufacturer | MEDTRONIC HEART VALVE DIVISION |
|---|---|
| Manufacturer group | MEDTRONIC HEART VALVE DIVISION |
| Product code | LWQ |
| Product code name | Heart-Valve, Mechanical |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Insufficient Information, No Information, No Known Impact Or Consequence To Patient, Inadequacy of Device Shape and/or Size, Adverse Event Without Identified Device or Use Problem, Incomplete Coaptation, Occlusion, No Code Available 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