FDA Adverse Event
Injury
Summary report: N
TRIFECTA STENTED TISSUE VALVE, IDE
MDR report key: 3201502
·
Received June 28, 2013
Report
- Report Number
- 8020430-2013-00004
- Event Type
- Injury
- Date Received
- June 28, 2013
- Date of Event
- June 21, 2013
- Report Date
- June 24, 2013
- Manufacturer
- ST. JUDE MEDICAL CANADA, INC.
- Product Code
- LWR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 67298 | TRIFECTA STENTED TISSUE VALVE, IDE | TISSUE (HEART VALVE | LWR | ST. JUDE MEDICAL CANADA, INC. | TF-25A-IDE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |