FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1096211
·
Received July 31, 2008
Report
- Report Number
- 1644487-2008-01747
- Event Type
- Malfunction
- Date Received
- July 31, 2008
- Date of Event
- July 2, 2008
- Report Date
- July 2, 2008
- 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
REPORTER INDICATED THAT AT A PT'S INITIAL DOSING APPOINTMENT, THE VNS GENERATOR WAS FOUND TO BE AT 1MA, 20HZ, 30 SECONDS ON TIME, AND 60 MINUTES OFF TIME. THE PHYSICIAN REPORTED THAT THERE WAS AN INTERRUPTED SYSTEM DIAGNOSTICS TEST AT THE OFFICE VISIT; HOWEVER, IT IS UNCLEAR IF THE UNINTENDED SETTINGS OCCURRED DUE TO THAT TEST OR BEFORE THE OFFICE VISIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR |