FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 936309
·
Received April 12, 2007
Report
- Report Number
- 1644487-2007-00209
- Event Type
- Malfunction
- Date Received
- April 12, 2007
- Date of Event
- March 9, 2007
- Report Date
- March 13, 2007
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LNX
- PMA / PMN Number
- p970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
RECEIVED A REPORT THAT THE SITE'S DELL HAND HELD WOULD DISPLAY AN ERROR MESSAGE AFTER INTERROGATION AND THE SCREEN WOULD LOCK IN THAT STATUS NOT ALLOWING FOR FURTHER NAVIGATION. THE PRODUCT WAS RETURNED TO CYBERONICS INC. FOR PRODUCT ANALYSIS. AN ANALYSIS WAS PERFORMED AND THE CAUSE FOR THE REPORTED COMPLAINT WAS ASSOCIATED WITH A CORRUPT DATABASE. THE CAUSE OF THE CORRUPT DATABASE IS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LNX | CYBERONICS, INC. | 250 | 345685 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |