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 2018-10-15 for NIM? EMG ELECTRODE 8227410 manufactured by Medtronic Xomed Inc..
[123745628]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[123745749]
A health care professional (hcp) reported they were having issues with their electrodes. When going into their electrode check, the status would stay green. Surgeon was no longer able to get a response on the system, it would just constantly beep as if it was constantly stimulating. They turned the channel off and the beeping went away, removed the electrodes and turned the channel back on, electrodes off was displayed, indicating that the interface box was working seeing the electrodes just fine. This confirmed that the nim was isolated with no other systems or chords close to it. The hcp rebooted the system and disconnected and reconnected the interface box. The leads were checked on the patient that they were still in place. The electrodes were unplugged and replugged into the interface box without resolution. The hcp decided to continue without the system. The procedure was in less than a hour. There was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2018-00513 |
| MDR Report Key | 7966254 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-10-15 |
| Date of Report | 2019-02-08 |
| Date of Event | 2018-09-18 |
| Date Mfgr Received | 2019-01-28 |
| Date Added to Maude | 2018-10-15 |
| 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 | URIZA SHUMS |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328405 |
| 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? EMG ELECTRODE |
| Generic Name | ELECTRODE, NEEDLE |
| Product Code | GXZ |
| Date Received | 2018-10-15 |
| Model Number | 8227410 |
| Catalog Number | 8227410 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-10-15 |