FDA Adverse Event
Injury
Summary report: N
MEDTRONIC
MDR report key: 515056
·
Received March 2, 2004
Report
- Report Number
- 515056
- Event Type
- Injury
- Date Received
- March 2, 2004
- Date of Event
- December 5, 2003
- Report Date
- March 1, 2004
- Manufacturer
- MEDTRONIC
- Product Code
- LWQ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REMOVAL AND REPLACEMENT OF STENOSED PROSTHETIC TRICUPSID VALVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDTRONIC | TRICUSPID VALVE | LWQ | MEDTRONIC | 305 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Hospitalization |