FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1792988
·
Received August 9, 2010
Report
- Report Number
- 1644487-2010-01826
- Event Type
- Malfunction
- Date Received
- August 9, 2010
- Date of Event
- July 21, 2010
- Report Date
- July 21, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
REPORTER INDICATED A VNS (B)(4) HANDHELD COMPUTER WOULD NOT HOLD A CHARGE. THE COMPUTER AND FLASHCARD HAVE BEEN RETURNED AND ARE CURRENTLY IN PRODUCT ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 521379 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |