FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1001223
·
Received February 22, 2008
Report
- Report Number
- 1644487-2008-00375
- Event Type
- Malfunction
- Date Received
- February 22, 2008
- Date of Event
- January 24, 2008
- Report Date
- January 24, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE MALFUNCTION IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
REPORTER INDICATED THAT HAND HELD PROGRAMMING COMPUTER WAS "FREEZING ALL THE TIME WHEN HE WOULD TRY AND INTERROGATE A PT". TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. THE HAND HELD HAS BEEN RETURNED TO THE MANUFACTURER AND IS PENDING PRODUCT ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 | 521404 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |