FDA Adverse Event
Death
Summary report: N
SJM MECHANICAL HEART VALVE
MDR report key: 1656765
·
Received April 9, 2010
Report
- Report Number
- 3001743903-2010-00026
- Event Type
- Death
- Date Received
- April 9, 2010
- Date of Event
- March 26, 2010
- Report Date
- April 9, 2010
- Manufacturer
- ST JUDE MEDICAL BRASIL LTDA.
- Product Code
- LWQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED, DURING THE IMPLANT PROCEDURE AND AFTER A 21 MM SJM EPIC VALVE (MEDWATCH REPORT# 3001743903-2010-00025) WAS IMPLANTED, AN AORTIC INSUFFICIENCY WAS DETECTED AND THE VALVE WAS REMOVED AND REPLACED WITH THIS SMALLER 19 MM MECHANICAL VALVE. THE PT DIED THE SAME DAY AS THE PROCEDURE. THE CAUSE OF DEATH IS UNK. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SJM MECHANICAL HEART VALVE | STANDARD HEART VALVE | LWQ | ST JUDE MEDICAL BRASIL LTDA. | 19A-101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Death |