FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1973524
·
Received January 19, 2011
Report
- Report Number
- 1644487-2011-00089
- Event Type
- Malfunction
- Date Received
- January 19, 2011
- Date of Event
- January 1, 2005
- Report Date
- December 20, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
IT WAS OBSERVED DURING REVIEW OF PROGRAMMING HISTORY FOR THE VNS PT'S DEVICE, THAT UPON INTERROGATION TWO WEEKS FOLLOWING INITIAL IMPLANTATION OF THE DEVICE, THE SETTINGS WERE NOTED TO BE AT THE SAME SETTINGS THAT THE SYSTEM DIAGNOSTIC TEST IS PERFORMED. THE FOLLOWING NEUROLOGIST HAD RE-PROGRAMMED THE DEVICE TO THE INTENDED SETTINGS AT THE OFFICE VISIT. IT APPEARS THAT THE EVENT MOST LIKELY OCCURRED DURING SURGERY AND THERE WAS AN INTERRUPTION IN COMMUNICATION DURING THE SYSTEM DIAGNOSTIC TEST WHICH CHANGED THE DEVICE SETTINGS TO SYSTEM TEST SETTINGS.
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 | 8 YR |