FDA Adverse Event
Malfunction
Summary report: N
NIM® 3.0 INTERFACE
MDR report key: 7067647
·
Received November 29, 2017
Report
- Report Number
- 1045254-2017-00432
- Event Type
- Malfunction
- Date Received
- November 29, 2017
- Date of Event
- November 2, 2017
- Report Date
- November 29, 2017
- Manufacturer
- MEDTRONIC XOMED INC.
- Product Code
- ETN
- PMA / PMN Number
- K083124
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PATIENT INTERFACE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. CONCOMITANT DEVICE NIM 3.0 MAINFRAME 8253001, SERIAL # (B)(4), LOT # N/A, 510K# K083124. 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 SURGEON REPORTED THERE WAS A PROBLEM WITH THE INTERFACE. NO PATIENT IMPACT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 847233 | NIM® 3.0 INTERFACE | STIMULATOR, NERVE | ETN | MEDTRONIC XOMED INC. | 8253200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |