FDA Adverse Event
Injury
Summary report: N
TRIFECTA STENTED TISSUE VALVE
MDR report key: 3201522
·
Received June 28, 2013
Report
- Report Number
- 3001743903-2013-00034
- Event Type
- Injury
- Date Received
- June 28, 2013
- Date of Event
- June 4, 2013
- Report Date
- June 6, 2013
- Manufacturer
- ST JUDE MEDICAL BRASIL
- Product Code
- LWR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FINAL MEDWATCH WILL BE SENT AT THE CONCLUSION OF OUR INVESTIGATION.
Description of Event or Problem · 1
THE INFORMATION PROVIDED TO SJM INDICATED A 23MM TRIFECTA VALVE WAS SELECTED FOR USE. THE PATIENT PRESENTED WITH ENDOCARDITIS ON (B)(6) 2013. THE CULTURE RESULTS SHOWED THE PRESENCE OF (B)(6) .
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 295380 | TRIFECTA STENTED TISSUE VALVE | STENTED TISSUE VALVE | LWR | ST JUDE MEDICAL BRASIL | TF-23A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization| R |