FDA Adverse Event
Malfunction
Summary report: N
SYNCHRO-14 NEURO-GUIDEWIRE
MDR report key: 709673
·
Received May 5, 2006
Report
- Report Number
- 6000078-2006-00117
- Event Type
- Malfunction
- Date Received
- May 5, 2006
- Report Date
- May 4, 2006
- Manufacturer
- NEUROVASCULAR, A DIV OF BOSTON SCIENTIFIC CORP
- Product Code
- DQX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
IN 3/06, BOSTON SCIENTIFIC CORP RECEIVED NOTIFICATION OF AN UNAUTHORIZED COMPLAINT, WHERE NO INFO WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRO-14 NEURO-GUIDEWIRE | GUIDEWIRE | DQX | NEUROVASCULAR, A DIV OF BOSTON SCIENTIFIC CORP | * | B06136 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |