FDA Adverse Event
Injury
Summary report: N
MASTERS SERIES MECHANICAL HEART VALVE
MDR report key: 3113726
·
Received May 10, 2013
Report
- Report Number
- 2648612-2013-00020
- Event Type
- Injury
- Date Received
- May 10, 2013
- Date of Event
- April 12, 2013
- Report Date
- April 15, 2013
- Manufacturer
- ST. JUDE MEDICAL PUERTO RICO
- Product Code
- LWQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- 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 PT UNDERWENT AN AORTIC VALVE REPLACEMENT ON (B)(6) 2012 WHERE THIS 23MM MASTER SERIES VALVE WAS USED. THE PT PRESENTED WITH ENDOCARDITIS AND THE VALVE WAS EXPLANTED ON (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 208820 | MASTERS SERIES MECHANICAL HEART VALVE | ROTATABLE HEART VALVE | LWQ | ST. JUDE MEDICAL PUERTO RICO | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Hospitalization| R |