MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-12-10 for MAINFRAME 8252001 NIM-RESPONSE 2.0 manufactured by Medtronic Xomed, Inc..
[3992608]
It was reported that the system's stimulus setting would not remain at the designated setting. System will be set at 1. 0 ma and when surgeon goes to stimulate, the setting goes to 0 ma and no stimulus is produced. They were able to change setting back to 1. 0 ma and continue using the system to complete case. There was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
[11383621]
(b)(4): product evaluation: no analysis results available; device has not been returned. Method: no testing methods performed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2013-00595 |
| MDR Report Key | 3511965 |
| Report Source | 06,07 |
| Date Received | 2013-12-10 |
| Date of Report | 2013-11-15 |
| Date of Event | 2013-11-15 |
| Date Mfgr Received | 2013-11-15 |
| Date Added to Maude | 2014-03-24 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELLE ALFORD |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328197 |
| 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 | 2013-12-10 |
| Model Number | 8252001 |
| Catalog Number | 8252001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2013-12-10 |