FDA Adverse Event
Injury
Summary report: N
RX ACCULINK CAROTID STENT SYSTEM
MDR report key: 706056
·
Received April 28, 2006
Report
- Report Number
- 3004742046-2006-00195
- Event Type
- Injury
- Date Received
- April 28, 2006
- Date of Event
- March 25, 2006
- Report Date
- March 27, 2006
- Manufacturer
- GUIDANT ENDOVASCULAR SOLUTIONS
- Product Code
- NIM
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THA TNON AN ADDITIONAL VISIT, 03/25/2006. THE PATIENT HAD EXPERIENCED A STROKE. THE REPORTED START DATE WAS 03/25/200006 WITH A STOP DATE ONE DAY LATER. THE CONDITION IF NOT CONTINUING AND WAS NOT PRE-EXISTING. NO ACTION/TREATMENT WAS GIVEN. THE EVENT RESULTED IN NEW HOSPITALIZATION AND THE PATIENT'S OUTCOME WAS REPORTED TO BE RESOLVED. RESUTS OF THE NIH STROKE SCALE ASSESSMENT ON 03/25/2006 INDICATED UNREMARKABLE NEUROLOGICAL EVENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RX ACCULINK CAROTID STENT SYSTEM | CAROTID STENT SYSTEM | NIM | GUIDANT ENDOVASCULAR SOLUTIONS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Disability |