FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2021830
·
Received February 25, 2011
Report
- Report Number
- 1644487-2011-00360
- Event Type
- Malfunction
- Date Received
- February 25, 2011
- Date of Event
- October 18, 2010
- Report Date
- January 27, 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
Description of Event or Problem · 1
DURING ANALYSIS OF THE VNS GENERATOR FOR MFR REPORT # 1644487-2010-02720, IT WAS FOUND UPON INTERROGATION THAT THE PT'S VNS GENERATOR WAS PROGRAMMED TO SETTINGS INDICATIVE OF A FAULTED DIAGNOSTICS TEST. IT IS UNK WHEN THE FAULTED DIAGNOSTICS TEST OCCURRED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE UNINTENDED SETTINGS. ATTEMPTS FOR FURTHER INFO ARE IN PROGRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |