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 2016-03-07 for NIM-NEURO? 2.0 MAINFRAME 8252401IP manufactured by Medtronic Xomed Inc..
[39801538]
This device is used for therapeutic purposes. (b)(4). The device was not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[39801539]
It was reported that during an inner ear surgery, the surgeon used the system's factory default setting for acoustic neurinoma (0. 8ma) instead of her preferred custom setting of 0. 03ma. She did not intend to use the default setting. The patient has facial nerve paralysis, and the surgeon alleges that the paralysis was caused by the stimulation level, and unrelated to surgical dissection. Reportedly, the patient experienced "very small recovery. "
Patient Sequence No: 1, Text Type: D, B5
[101833262]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2016-00067 |
| MDR Report Key | 5483947 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-03-07 |
| Date of Report | 2016-02-12 |
| Date of Event | 2016-01-12 |
| Date Mfgr Received | 2016-02-12 |
| Device Manufacturer Date | 2007-10-26 |
| Date Added to Maude | 2016-03-07 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AMY CORRALES |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328138 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| 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? 2.0 MAINFRAME |
| Generic Name | ELECTROMYOGRAPH, DIAGNOSTIC |
| Product Code | IKN |
| Date Received | 2016-03-07 |
| Model Number | 8252401IP |
| Catalog Number | 8252401IP |
| Lot Number | 53057300 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Required No Informationntervention | 2016-03-07 |