FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1081945
·
Received July 23, 2008
Report
- Report Number
- 1644487-2008-01694
- Event Type
- Malfunction
- Date Received
- July 23, 2008
- Date of Event
- June 1, 2008
- Report Date
- June 26, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE MALFUNCTION SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
INITIAL REPORTER INDICATED THAT THE SITE'S DELL X5 HANDHELD SCREEN ALIGN WOULD NOT COMPLETE. A RESET DID NOT RESOLVE THE PROBLEM. MANUFACTURER PENDING RECEIPT OF PRODUCT FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 | 366959 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |