MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-22 for MEDTRONIC EMG ELECTRODE 8227304 manufactured by Medtronic Xomed, Inc..
[146200071]
Situation - pt sustained a burn to the floor of the mouth during a neurostimulator implant case. Background - the pt was undergoing surgery to have a neurostimulator (inspira) implanted. The surgeon had placed medtronic electrodes in the mouth and, according to the surgeon, the blue lead was not functioning properly. The blue lead was removed and it was noted that the pt had sustained a minor burn to the floor of the mouth on the left side. The blue lead was replaced and the surgery was proceeded with no further complications. Assessment - the blue lead did not work properly and the pt sustained a burn. The surgeon did not recommend any add'l treatments. Recommendation - only the blue lead was defective out of the package which includes four leads. The defective lead was retained. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086843 |
| MDR Report Key | 8636186 |
| Date Received | 2019-05-22 |
| Date of Report | 2019-05-21 |
| Date of Event | 2019-05-20 |
| Date Added to Maude | 2019-05-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDTRONIC EMG ELECTRODE |
| Generic Name | NEEDLE, DIAGNOSTIC ELECTROMYOGRAPH |
| Product Code | IKT |
| Date Received | 2019-05-22 |
| Catalog Number | 8227304 |
| Lot Number | 0217033923 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-22 |