MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2017-08-10 for NIM? EMG ELECTRODE XOM UNK NIMELECTRO manufactured by Medtronic Xomed Inc..
[82447268]
Link to article: https://link. Springer. Com/article/10. 1007/s00268-015-3368-y. Concomitant devices: -- unknown nim flex emg tube -- unknown nim response 3. 0 mainframe -- unknown nim response 3. 0 patient interface. Product evaluation: analysis results are not available; device not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[82447269]
Results reported in? Impact of emg changes in continuous vagal nerve monitoring in high-risk endocrine neck surgery? , brauckhof k. , et al. , world j surg (2016) 40:672? 680. Hypothesis:? Continuous vagal intraoperative neuromonitoring (cionm) of the recurrent laryngeal nerve (rln) may reduce the risk of rln lesions during high-risk endocrine neck surgery such as operation for large goiter potentially requiring transsternal surgery, advanced thyroid cancer, and recurrence.? This article was conducted to evaluate whether continuous intraoperative nerve monitoring would lower the risk of rln lesions during high-risk endocrine neck surgery. The nim system, emg tube and aps probe were used to record the nerve function throughout the procedures, not to identify nerves. The loss in amplitude reported is a diagnostic tool used by the surgeon to aid in preventing nerve injury. If the amplitude drops below a certain percent, the surgeon knows that unless he makes an adjustment, vocal cord injury could occur. This study reports 1 patient who sustained permanent vocal cord palsy due to an intrinsic? Acute thermic? Lesion. ? In total, there were 87 nerves at risk (nar), 42 on the right and 45 on the left side. Laryngoscopy on the first postoperative day revealed three immobile vocal cords (3. 4 %related to nar) in three patients. Two were normal after 6 months, resulting in a permanent palsy rate of 1. 1 %relative to nar.?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2017-00276 |
| MDR Report Key | 6785943 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2017-08-10 |
| Date of Report | 2017-07-14 |
| Date Mfgr Received | 2017-07-14 |
| Date Added to Maude | 2017-08-10 |
| 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 | MICHELLE ALFORD |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328197 |
| Manufacturer G1 | MEDTRONIC XOMED INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR NORTH |
| 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 | 2017-08-10 |
| Model Number | XOM UNK NIMELECTRO |
| Catalog Number | XOM UNK NIMELECTRO |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2017-08-10 |