FDA Adverse Event
Malfunction
Summary report: N
NIM® 3.0 MAINFRAME
MDR report key: 7100415
·
Received December 8, 2017
Report
- Report Number
- 1045254-2017-00450
- Event Type
- Malfunction
- Date Received
- December 8, 2017
- Date of Event
- October 23, 2017
- Report Date
- December 8, 2017
- Manufacturer
- MEDTRONIC XOMED INC.
- Product Code
- ETN
- UDI-DI
- 00643169871014
- PMA / PMN Number
- K083124
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE(S) MAINFRAME, PATIENT INTERFACE, AND THE MUTING PROBE WERE RETURNED AND EVALUATED, NO FUNCTIONAL FAULT WAS FOUND WITH THE DEVICES. CONCOMITANT MEDICAL PRODUCTS: PRODUCT # 8253200RF, PRODUCT DESCRIPTION PATIENT INTERFACE, SERIAL # (B)(4), LOT # 212171821, MANUFACTURE DATE- OCTOBER 20, 2016, 510(K) # K083124, UDI # (B)(4), PRODUCT # 8220325, PRODUCT DESCRIPTION MUTING PROBE, UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED DURING TESTING THE DEVICE IS NOT READING ESOPHAGEAL STIMULATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 879309 | NIM® 3.0 MAINFRAME | STIMULATOR, NERVE | ETN | MEDTRONIC XOMED INC. | 8253001RF | 208282456 | 00643169871014 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |