FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2191918
·
Received July 22, 2011
Report
- Report Number
- 1644487-2011-01663
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- July 13, 2011
- Report Date
- June 24, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF PROGRAMMING/DEVICE DIAGNOSTIC HISTORY.
Description of Event or Problem · 1
IN REVIEW OF THE MFR'S PROGRAMMING HISTORY DATABASE IT WAS NOTICED THAT THE PT CAME INTO AN APPOINTMENT AT INTENTIONAL SETTING CHARACTERISTIC OF AN INCOMPLETE DIAGNOSTICS. THERE WERE DIAGNOSTICS THAT WERE RUN AT THE PREVIOUS APPOINTMENT WAS NO FINAL INTERROGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 521385 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR |