MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®; STIMULATOR, NERVE

Model Number	8229737
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Hypoxia (1918); Extubate (2402); Low Oxygen Saturation (2477)
Date of Event	02/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported via a manufacturer representative that during a thyroid surgery, an act for which the anesthetist does not have access to the patient's head, the patient desaturated (sat o2 at 70%, pet co2>60mmhg) and the anesthetist cannot ventilate it.Intervention interrupted.Surgical fields removed to access the upper airways.The probe [emg tube] is in place but a double plication (fold) is noticed, that subsequently resulted in the probe [emg tube] replaced by an armored nim probe.Re-intubation of the patient intraoperatively, outside the standard procedure and under hazardous conditions.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was confirmed by the rep that the complaint was double plication (pleading).The septic field rupture on open cervicotomy was the same event.The complaint stated that this kind of incident had happened before.It was clarified that an armed nim probe is an armored nim probe and they switched with a flex tube to reintubated the patient.Additional information received from rep stating that the standard practice for intubation is by using a stylet.The hcp use an adhesive band/strip to fix the tube during the procedure.After reintubation, the procedure was successfully completed.The patient is currently ok.Additional information received from rep stating that the standard practice for intubation is by using a stylet.The hcp use an adhesive band/strip to fix the tube during the procedure.After reintubation, the procedure was successfully completed.The patient is currently ok.

• Brand Name: NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8687325
• Report Number: 1045254-2019-00287
• Device Sequence Number: 19570220
• Product Code: ETN
• UDI-Device Identifier: 00643169782648
• UDI-Public: 00643169782648
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/10/2022
• Device Model Number: 8229737
• Device Catalogue Number: 8229737
• Device Lot Number: 0216195086
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention