FDA Adverse Event
Death
Summary report: N
COMPLETE SE SFA - IDE
MDR report key: 3451588
·
Received November 6, 2013
Report
- Report Number
- 2953200-2013-01209
- Event Type
- Death
- Date Received
- November 6, 2013
- Date of Event
- April 22, 2013
- Report Date
- October 15, 2013
- Manufacturer
- MEDTRONIC CARDIOVASCULAR SANTA ROSA
- Product Code
- NIP
- PMA / PMN Number
- K062264
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 574406 | COMPLETE SE SFA - IDE | STENT, SUPERFICIAL FEMORAL ARTERY | NIP | MEDTRONIC CARDIOVASCULAR SANTA ROSA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Death |