FDA Adverse Event
Injury
Summary report: N
CYPHER STENT
MDR report key: 498909
·
Received November 18, 2003
Report
- Report Number
- MW1030324
- Event Type
- Injury
- Date Received
- November 18, 2003
- Date of Event
- October 5, 2003
- Report Date
- November 15, 2003
- Manufacturer
- J & J
- Product Code
- NIQ
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
SUBACUTE THROMBOSIS 48HR AFTER PLACEMENT OF A CYPHER STENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYPHER STENT | * | NIQ | J & J | * | 40803836 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Hospitalization| L| R |