FDA Adverse Event
Malfunction
Summary report: N
NIM-ECLIPSE® DESKTOP COMPUTER
MDR report key: 7105995
·
Received December 11, 2017
Report
- Report Number
- 1045254-2017-00453
- Event Type
- Malfunction
- Date Received
- December 11, 2017
- Report Date
- December 11, 2017
- Manufacturer
- MEDTRONIC XOMED INC.
- Product Code
- GWF
- UDI-DI
- 00643169221000
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT MARKETED IN THE US; SIMILAR DEVICE AVAILABLE. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
THE DEVICE RETURN INDICATED FOR AN ALLEGED MALFUNCTION, SPECIFICS WERE NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 885317 | NIM-ECLIPSE® DESKTOP COMPUTER | STIMULATOR, ELECTRICAL, EVOKED RESPONSE | GWF | MEDTRONIC XOMED INC. | NWCPU | NI | 00643169221000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |