MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-31 for NIM? EMG ELECTRODE 8227411 manufactured by Medtronic Xomed Inc..
[84449280]
One opened sample of part number 8227411, from lot number j314645 was received. There was a residue consistent with biological contaminants on the device. Only the violet electrode was returned. Visually, there was no damage or anomalies in the construction of the device that would have resulted in the reported event. The paired subdermal electrodes shall exhibit continuity from needle tip to connecting pin with a measurement less than 2. 0ohms [and shall exhibit infinity between needles and connectors]; the actual measurement was 1. 7ohms / 1. 7ohms; there was an infinite between poles and no out of specification condition was identified. This is a supplied material assembly with no out of specification condition therefore manufacturing and supplier have been ruled out as likely causes. The instructions for use identifies multiple reasons for a reduced, if not completely eliminate, emg responses to direct or passive neural stimulation [as a result of use error]. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[84449281]
The facility reported that the when the device was stimulated, there was no sensing. The nerve location was known but the device was not detecting the nerve. The procedure was completed with another set of electrodes. There was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2017-00299 |
| MDR Report Key | 6835396 |
| Date Received | 2017-08-31 |
| Date of Report | 2017-08-07 |
| Date of Event | 2017-08-07 |
| Date Mfgr Received | 2017-08-07 |
| Device Manufacturer Date | 2016-08-30 |
| Date Added to Maude | 2017-08-31 |
| 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 | SHARANYA JANGITI |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328183 |
| 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 | 0 |
| Brand Name | NIM? EMG ELECTRODE |
| Generic Name | ELECTRODE, NEEDLE, DIAGNOSTIC ELECTROMYOGRAPH |
| Product Code | IKT |
| Date Received | 2017-08-31 |
| Returned To Mfg | 2017-08-29 |
| Model Number | 8227411 |
| Catalog Number | 8227411 |
| Lot Number | J314645 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-08-31 |