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 2018-06-15 for NIM? EMG ELECTRODE 8227411 manufactured by Medtronic Xomed Inc..
[111202757]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[111202758]
A distributor reported that the device had a short circuit during the operation and the nerve could not be tested during the operation but was able to be used after the replacement. It was noted that there were no patient symptoms or complications associated with the event.
Patient Sequence No: 1, Text Type: D, B5
[114475655]
Analysis of the returned device indicated that visually, there was no damage or anomalies in the construction of the device that would have resulted in the reported event. The green electrode end to end ohms resistance shall be less than 2. 5 ohms; the actual measurements was 1. 2 ohms indicating an in-specification condition. The paired electrode packages were opened for further analysis. The resistance between paired electrode cables shall measure less than 2. 0 ohms and the actual measurements were; both pole of the red and blue = 1. 8 ohms, both poles of the orange and violet = 1. 4 ohms; there were no short circuits; all measurements were within tolerance. There was no out of specification condition identified as it relates to the complaint. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2018-00249 |
| MDR Report Key | 7605867 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-06-15 |
| Date of Report | 2018-10-03 |
| Date of Event | 2018-04-18 |
| Date Mfgr Received | 2018-08-08 |
| Device Manufacturer Date | 2017-08-21 |
| Date Added to Maude | 2018-06-15 |
| 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 DR. N. |
| 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 | 2018-06-15 |
| Returned To Mfg | 2018-06-13 |
| Model Number | 8227411 |
| Catalog Number | 8227411 |
| Lot Number | 0213878681 |
| 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 | 2018-06-15 |