MAUDE Adverse Event Report: MEDTRONIC XOMED, INC. NIM CONTACT EMG ENDOTRACHEAL TUB; STIMULATOR, NERVE

Model Number	8229507
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Using medtronic nims endotracheal tube placed with videoscope, ventilated well for several minutes then high peak pressures/no ventilation, assessment and treatment of patient, ventilation only improved when tube replaced with standard endotracheal tube.

• Brand Name: NIM CONTACT EMG ENDOTRACHEAL TUB
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED, INC.
• MDR Report Key: 17337130
• Report Number: MW5119519
• Device Sequence Number: 12488557
• Product Code: ETN
• UDI-Device Identifier: 00643169789562
• UDI-Public: 00643169789562
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8229507
• Device Lot Number: 0226495592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/14/2023
• 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: Life Threatening
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White