FDA Adverse Event
Malfunction
Summary report: N
PATHFINDER 020, 6, 2-5-2, 135
MDR report key: 505173
·
Received December 16, 2003
Report
- Report Number
- 2951009-2003-00013
- Event Type
- Malfunction
- Date Received
- December 16, 2003
- Date of Event
- November 6, 2003
- Report Date
- December 15, 2003
- Manufacturer
- CARDIMA, INC.
- Product Code
- DRF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PATHFINDER 020, 6, 2-5-2, 135 | PATHFINDER | DRF | CARDIMA, INC. | 01-063006 | M2004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |