FDA Adverse Event
Malfunction
Summary report: N
NIM® 3.0 INTERFACE
MDR report key: 7062382
·
Received November 27, 2017
Report
- Report Number
- 1045254-2017-00428
- Event Type
- Malfunction
- Date Received
- November 27, 2017
- Date of Event
- November 2, 2017
- Report Date
- November 27, 2017
- Manufacturer
- MEDTRONIC XOMED INC.
- Product Code
- ETN
- UDI-DI
- 00643169782501
- PMA / PMN Number
- K083124
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
PATIENT INTERFACE (B)(6). THE PRODUCT ANALYSIS INDICATED THE DEVICE CABLE REQUIRED REPLACEMENT DUE TO FAILURE. THE CABLE WAS REPLACED. THE DEVICE WAS REPAIRED AND TESTED TO SPECIFICATIONS. NIM MAINFRAME 3.0 - (B)(4). SERVICE DID NOT FIND FAULT WITH THE DEVICE. THE DEVICE WAS TESTED TO SPECIFICATION AND RETURNED TO THE CUSTOMER. CONCOMITANT DEVICE: (B)(4) ,NIM MAINFRAME 3.0, SERIAL #(B)(4), LOT # 69222500, 510K # K083124, UDI # (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THEY WERE UNABLE TO DO ANY NERVE STIMULATION OR RECEIVE NERVE FEEDBACK INTRAOPERATIVELY. THERE WAS NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 837663 | NIM® 3.0 INTERFACE | STIMULATOR, NERVE | ETN | MEDTRONIC XOMED INC. | 8253200RF | 71463100 | 00643169782501 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |