FDA Adverse Event
Death
Summary report: N
JOHNSON & JOHNSON (CORDIS)
MDR report key: 1022242
·
Received April 1, 2008
Report
- Report Number
- MW5006085
- Event Type
- Death
- Date Received
- April 1, 2008
- Date of Event
- October 12, 2007
- Manufacturer
- CORDIS
- Product Code
- NIQ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT HAD BARE METAL STENTS AND DRUG ELUTING STENTS WITH HIS HEART. THE DES WAS PLACED IN HIS LAD IN APRIL 2003 AFTER BEING APPROVED BY THE FDA. PT SUFFERED A SUDDEN DEATH IN 2007.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JOHNSON & JOHNSON (CORDIS) | CYPHER STENT | NIQ | CORDIS | * | A1102356 | |
| 2 | JOHNSON & JOHNSON (CORDIS) | CYPHER STENT | NIQ | CORDIS | A0203782 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Death |