MAUDE report
MAUDE report 47399: FREESTYLE AORTIC ROOT BIOPROSTHESIS
Malfunction · received Oct 30, 1996 · MEDTRONIC HEART VALVES, INC.
Key facts
| MDR report key | 47399 |
|---|---|
| Report number | 2025587-1996-00026 |
| Event type | Malfunction |
| Brand name | FREESTYLE AORTIC ROOT BIOPROSTHESIS |
| Model number | 995 |
| Catalog number | A99521 |
| Manufacturer | MEDTRONIC HEART VALVES, INC. |
| Product code | LWR |
| Device class | Class III |
| Date received by FDA | Oct 30, 1996 |
| Report date | Oct 1, 1996 |
| Report source | Maude |
At a glance
- None Device problems coded
- 1,000+ MAUDE reports for this product code
- 1,000+ MAUDE reports for this brand
- 100–999 Death reports for this brand
- 1,000+ Injury reports for this brand
- No Adverse event flagged
- Yes Product problem flagged
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE medical device reports
MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.
Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date: