FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1232731
·
Received November 14, 2008
Report
- Report Number
- 1644487-2008-02768
- Event Type
- Malfunction
- Date Received
- November 14, 2008
- Date of Event
- April 1, 2008
- Report Date
- October 16, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS FOUND THAT A PATIENT'S VNS DEVICE WAS FOUND TO BE RESET TO 0MA UPON INITIAL INTERROGATION AT A ROUTINE OFFICE VISIT. THE LAST OFFICE VISIT HAD BEEN SIX MONTHS PRIOR WHERE THE OUTPUT CURRENT WAS THOUGHT TO BE SET AT 1.0 MA. FOLLOWUP WITH THE PHYSICIAN REVEALED THAT AN INTERRUPTED DIAGNOSTIC TEST HAD OCCURRED AT THE LAST OFFICE VISIT. THE INTERRUPTED DIAGNOSTIC TEST CAUSED THE DEVICE TO RESET TO DIFFERENT SETTINGS. THE PHYSICIAN PROGRAMMED THE PATIENT TO THE CORRECT SETTINGS.
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 | 23 YR |