MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-01-14 for NIM? EMG ELECTRODE 8227411 manufactured by Medtronic Xomed Inc..
[133050140]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[133050141]
A health care provider (hcp) reported via a distributor that after all the electrodes were set for a parotidectomy procedure, the doctor confirmed that all electrodes on the monitor were checked. However, when the doctor did further testing by patting the patient's face, he found that there was no reaction from the nerves of chin, the purple electrode. The doctor tried to reset the electrode and checked all the connections, however there was still no reaction. Finally, the doctor used a different purple electrode to complete the surgery. The second purple electrode could function properly with the same mainframe. There was no error code displayed on the monitor. The hcp noted that it was the initial use of the electrode. The problem was noticed during testing, therefore there was no stim value since the doctor had not used the probe when the problem was noticed. The surgery was delayed for about 10 minutes. There was no patient impact or injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2019-00024 |
| MDR Report Key | 8245807 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-01-14 |
| Date of Report | 2019-03-07 |
| Date of Event | 2018-12-13 |
| Date Mfgr Received | 2019-02-11 |
| Device Manufacturer Date | 2018-01-19 |
| Date Added to Maude | 2019-01-14 |
| 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 | 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 | 2019-01-14 |
| Returned To Mfg | 2019-02-06 |
| Model Number | 8227411 |
| Catalog Number | 8227411 |
| Lot Number | 0214752169 |
| 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 | 2019-01-14 |