MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07,company representati report with the FDA on 2014-03-19 for MAINFRAME 8252001 NIM-RESPONSE 2.0 manufactured by Medtronic Xomed, Inc..
[4298136]
It was reported that they were not getting a response when attempting to stimulate the nerve with the nim response 2. 0. They had their stim set to 1. 0ma and threshold at 100ua. They tried lowering the threshold but this did not resolve the issue. Surgeon was aborting use of nim. There was no impact on patient outcome.
Patient Sequence No: 1, Text Type: D, B5
[11552966]
This device is used for therapeutic purposes. (b)(4). The product has not been returned for analysis. No testing methods performed.
Patient Sequence No: 1, Text Type: N, H10
[101907953]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2014-00064 |
| MDR Report Key | 3688529 |
| Report Source | 05,06,07,COMPANY REPRESENTATI |
| Date Received | 2014-03-19 |
| Date of Report | 2014-02-26 |
| Date of Event | 2014-02-26 |
| Date Mfgr Received | 2014-02-26 |
| Date Added to Maude | 2014-05-19 |
| 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 | MAINFRAME 8252001 NIM-RESPONSE 2.0 |
| Generic Name | ELECTROMYOGRAPH, DIAGNOSTIC |
| Product Code | IKN |
| Date Received | 2014-03-19 |
| Model Number | 8252001 |
| Catalog Number | 8252001 |
| 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 DRIVE NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-19 |