MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-13 for NIM? EMG - ENDOTRACHEAL TUBE - TRIVANTAGE? XOM UNK TRIVANTAGE manufactured by Medtronic Xomed Inc..
[183373936]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183373937]
A healthcare provider (hcp) reported that there were no issues during intubation for a total thyroidectomy to remove a large compressive goiter; the patient had an awake, flexible intubation. At the end of the case, both nerves stimulated; there was no device malfunction alleged. The patient was extubated 3 days after the thyroidectomy. Five days after the surgery the patient returned for exploration, at which time it looked like she had an endolaryngeal burn, irritation and superficial ulceration, described as macerated tissue. She was treated with steroids and taken for exploration and was found to have subglottic stenosis; a tracheostomy was performed. The patient is currently doing well without any issue at all and was decannulated a long time ago.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2020-00157 |
| MDR Report Key | 9830977 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2016-09-14 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-03-13 |
| 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 | 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 - TRIVANTAGE? |
| Generic Name | STIMULATOR, NERVE |
| Product Code | ETN |
| Date Received | 2020-03-13 |
| Model Number | XOM UNK TRIVANTAGE |
| Catalog Number | XOM UNK TRIVANTAGE |
| 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 | 1. Required No Informationntervention | 2020-03-13 |