MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-30 for NIM-NEURO? 3.0 MAINFRAME 8253402 manufactured by Medtronic Xomed Inc..
[178628156]
Other relevant device(s) are: product id: 8253410, serial/lot #: (b)(4), udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[178628157]
A healthcare provider (hcp) reported that a nerve monitoring device was not working properly. In mode 1 it does not work and in mode 2, according to the service it gives failure. There was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
[183608719]
Analysis for the mainframe found out that the device has been received in good condition, there are no deviations found. Analysis for the interface found out that wave spring washers are worn. The fuse of channel stim 1 is defect. The parts have been replaced. The interface has been successfully tested according to manufacturers specifications. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2020-00065 |
| MDR Report Key | 9647845 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-30 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-01-07 |
| Device Manufacturer Date | 2017-11-30 |
| Date Added to Maude | 2020-01-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTY CAIN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328353 |
| Manufacturer G1 | MEDTRONIC XOMED INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NIM-NEURO? 3.0 MAINFRAME |
| Generic Name | STIMULATOR, NERVE |
| Product Code | ETN |
| Date Received | 2020-01-30 |
| Returned To Mfg | 2020-02-04 |
| Model Number | 8253402 |
| Catalog Number | 8253402 |
| Lot Number | 214472853 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-30 |