MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-17 for NIM? EMG - ENDOTRACHEAL TUBE 8229507 manufactured by Medtronic Xomed Inc..
[180612783]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[180612784]
A healthcare provider (hcp) reported that before surgery, the device's functionality was tested with the patient simulator, both channels (red and blue) work perfectly to the stimulus applied with the monopolar probe, the tubes are shown with their technical specifications and mode of use. When the return and ground electrodes are intuited and placed, the electrodes are checked on the nim screen showing impedances within normal limits with an event threshold of 100 uv. Anesthetist uses moderate-length muscle relaxant, which according to its dosage, its clinical duration can vary from 50 to 110 minutes. At 45 minutes the medical team begins the search for the nerve with the monopolar probe, demanding that the relaxation be reversed. At minute 65 they identify the nerve (visually) but the nim does not give any response. An electrode, muscle relaxation check is done, but the nerve cannot be identified during the 4 hours of surgery. In the final part of the surgery, the anesthetist realizes that there is a leak in the ventilation and has to inflate the cuff again. Patient was alive-no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2020-00091 |
| MDR Report Key | 9718712 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-17 |
| Date of Report | 2020-02-17 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-01-23 |
| Date Added to Maude | 2020-02-17 |
| 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 | CHRISTY CAIN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328353 |
| 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 - ENDOTRACHEAL TUBE |
| Generic Name | STIMULATOR, NERVE |
| Product Code | ETN |
| Date Received | 2020-02-17 |
| Model Number | 8229507 |
| Catalog Number | 8229507 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-02-17 |