FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1053194
·
Received May 27, 2008
Report
- Report Number
- 1644487-2008-01230
- Event Type
- Malfunction
- Date Received
- May 27, 2008
- Date of Event
- April 29, 2008
- Report Date
- April 29, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, 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 THEIR DELL X5 HANDHELD COMPUTER WOULD NOT "COMMUNICATE". THE PROGRAMMING WAND WAS RULED OUT AS A SOURCE OF THE COMMUNICATION ISSUE. THE HANDHELD COMPUTER IS AT MANUFACTURER PENDING COMPLETION OF PRODUCT ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 | 521407 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |