FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 4243461
·
Received November 11, 2014
Report
- Report Number
- 1644487-2014-02986
- Event Type
- Malfunction
- Date Received
- November 11, 2014
- Date of Event
- October 14, 2014
- Report Date
- October 14, 2014
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN ASSISTANT
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S SETTINGS WERE DIFFERENT THAN LAST PROGRAMMED. THE PATIENT HAD BEEN HAVING AN INCREASE IN SEIZURES AND IT WAS FOUND THAT THE SETTINGS WERE OFF RATHER THAN PROGRAMMED TO 2MA. THE SETTINGS WERE CORRECTED. THE CHANGE IN SETTINGS IS LIKELY THE RESULT OF A FAULTED DIAGNOSTIC TEST. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 725339 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS INC | MODEL 250 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR |