FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1031297
·
Received April 17, 2008
Report
- Report Number
- 1644487-2008-00947
- Event Type
- Malfunction
- Date Received
- April 17, 2008
- Date of Event
- January 1, 2008
- Report Date
- March 19, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED TO MFR THAT THE HAND HELD SCREEN CONTINUED TO FREEZE DURING INTERROGATION AND "THE SCREEN GOES COMPLETELY BLANK DURING SYSTEM DIAGNOSTICS". TROUBLESHOOTING WAS PERFORMED TO TEMPORARILY RESOLVE THE ISSUE, HOWEVER, THE SITE REQUESTED A NEW HAND HELD AND SOFTWARE BE SENT TO REPLACE THE NON-WORKING DEVICE. THE HAND HELD AND SOFTWARE HAVE BEEN RETURNED TO MFR AND ANALYSIS IS UNDERWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | NONE | LYJ | CYBERONICS, INC. | 250 | 521340 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |