FDA Adverse Event
Death
Summary report: N
J & J CYPHER STENT
MDR report key: 792865
·
Received December 10, 2006
Report
- Report Number
- MW1041316
- Event Type
- Death
- Date Received
- December 10, 2006
- Date of Event
- September 4, 2006
- Report Date
- December 10, 2006
- Manufacturer
- J & J
- Product Code
- NIQ
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CT, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
SUDDEN DEATH, CORONARY STENT CORONARY INFARC: COLLAPSED ON GOLF COURSE, TURNING BLUE. IMMEDIATE EFFORTS AT CPR FOLLOWED, FOLLOWED BY - 17 MINUTES LATER - EMT REMOVAL TO HOSP. ESSENTIALLY DOA. HAD SINGLE J&J CYPHER STENT -CXS08250- PLACED IN HIS LEFT ANTERIOR DESCENDING CORONARY ARTERY IN 2005 FOR ACUTE ANTERIOR MI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | J & J CYPHER STENT | * | NIQ | J & J | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Death |