FDA Adverse Event
Malfunction
Summary report: N
NICOLETONE SOFTWARE WITH CORTICAL STIMULATOR
MDR report key: 2298359
·
Received October 7, 2011
Report
- Report Number
- 3008289288-2011-00007
- Event Type
- Malfunction
- Date Received
- October 7, 2011
- Date of Event
- September 9, 2011
- Report Date
- October 7, 2011
- Manufacturer
- CAREFUSION 209 INC.
- Product Code
- GYC
- PMA / PMN Number
- K072964
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A VOLUNTARY FIELD CORRECTION AND REMOVAL, 806.10 WAS INITIATED (B)(4) 2011 TO THE (B)(6) OFFICE, REPORT NUMBER: (B)(4).
Description of Event or Problem · 1
UNDER CERTAIN CIRCUMSTANCES, WHEN USING NICOLETONE WITH THE NICOLET CORTICAL STIMULATOR, IT IS POSSIBLE THAT EVEN THOUGH STIMULATION WAS DELIVERED THROUGH THE SELECTED ELECTRODES, THE ANNOTATION LABEL WILL INCORRECTLY INDICATED THAT THE STIMULATION WAS DELIVERED VIA A DIFFERENT ELECTRODE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NICOLETONE SOFTWARE WITH CORTICAL STIMULATOR | NICOLETONE SOFTWARE | GYC | CAREFUSION 209 INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |