FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1203125
·
Received October 17, 2008
Report
- Report Number
- 1644487-2008-02511
- Event Type
- Malfunction
- Date Received
- October 17, 2008
- Date of Event
- September 19, 2008
- Report Date
- September 19, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ERROR MESSAGE WAS OBTAINED DURING A PROGRAMMING SESSION FOR A VNS PT. THE MESSAGE "OUTPUT CURRENT SET TO 0MA" WAS OBTAINED AFTER INTERROGATING THE PT'S DEVICE. THE PT IS PROGRAMMED AT 3.25 MA OUTPUT CURRENT SO THE NURSE DID NOT UNDERSTAND WHY THE ERROR MESSAGE "OUTPUT CURRENT SET TO 0 MA" WAS OBTAINED. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION INCLUDING PRODUCT IDENTIFIERS AND PRODUCT BACK FOR ANALYSIS 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 | 16 YR |