FDA Adverse Event
Malfunction
Summary report: N
NIM-ECLIPSE® PATIENT MODULE
MDR report key: 7086073
·
Received December 6, 2017
Report
- Report Number
- 1045254-2017-00446
- Event Type
- Malfunction
- Date Received
- December 6, 2017
- Report Date
- December 6, 2017
- Manufacturer
- MEDTRONIC XOMED INC.
- Product Code
- GWF
- UDI-DI
- 00613994870810
- PMA / PMN Number
- K061639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT ANALYSIS INDICATE CHANNEL 5 ELECTRODE WAS FAULTY. THE ELECTRODE BOARD WAS REPLACED AND THE DEVICE WAS TESTED TO MANUFACTURING SPECIFICATIONS. CONCOMITANT DEVICE: PRODUCT# AND NAME ¿ NIM ECLIPSE CONTROLLER , SERIAL # (B)(4), LOT # 206906937, 510K # K061639, UDI # (B)(4). THE DEVICE WAS EVALUATED AND NO FAULT WAS FOUND. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
THE DEVICE WAS RETURNED FOR AN ALLEGED MALFUNCTION, SPECIFICS WERE NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 868514 | NIM-ECLIPSE® PATIENT MODULE | STIMULATOR, ELECTRICAL, EVOKED RESPONSE | GWF | MEDTRONIC XOMED INC. | OPM660 | 210829996 | 00613994870810 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |