FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2181239
·
Received July 8, 2011
Report
- Report Number
- 1644487-2011-01537
- Event Type
- Malfunction
- Date Received
- July 8, 2011
- Date of Event
- February 1, 2011
- Report Date
- June 8, 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
- Health Professional
- Yes
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE PHYSICIAN THAT THE PT PRESENTED TO OFFICE AND WHEN THE VNS WAS INTERROGATED, IT WAS FOUND THAT THE PT WAS AT 0MA OUTPUT CURRENT, WHICH WAS NOT INTENDED. IT IS UNK WHAT THE REST OF THE SETTINGS WERE. THE LAST TIME THE PT WAS IN THE OFFICE WAS IN (B)(6) 2011 AND SHE WAS AT 1.75MA OUTPUT CURRENT. AN INTERRUPTED SYSTEM DIAGNOSTIC TEST MAY HAVE OCCURRED TO CAUSE THE SETTING CHANGE. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.
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 | Female |