FDA Adverse Event
Death
Summary report: N
J & J CORDIS
MDR report key: 547962
·
Received July 1, 2004
Report
- Report Number
- MW1032511
- Event Type
- Death
- Date Received
- July 1, 2004
- Date of Event
- April 12, 2004
- Report Date
- July 1, 2004
- Manufacturer
- JOHNSON & JOHNSON
- Product Code
- NIQ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
EMERGENCY INTERVENTION PERFORMED ON CIRCUMFLEX WITH DES. THE NEXT DAY INTERVENTION PERFORMED ON LAD WITH DES. TWENTY-FOUR DAYS LATER FOUND TO BE OCCLUDED. ANGIOJET AND PTCA PERFORMED. POST PROCEDURE PT SUFFERED COMPLICATION CAUSING A RETROPERITONEAL BLEED. PRONOUNCED DEAD AT 7:25 PM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | J & J CORDIS | CYPHER ELUTING STENT | NIQ | JOHNSON & JOHNSON | CXS18250 | A0104013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Death| H| R |