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

Model Number	8229707
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Extubate (2402)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned.A product analysis has not been performed.
Event or Problem Description
It was reported that during a surgery, the endotracheal emg tube had gotten a hole in it and had to be replaced.Follow-up information indicates that there was no patient injury.However, the tube was removed and replaced.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 6395257
• Report Number: 1045254-2017-00081
• Device Sequence Number: 16153863
• Product Code: ETN
• UDI-Device Identifier: 00643169060791
• UDI-Public: 00643169060791
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K112686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2017

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 Model Number: 8229707
• Device Catalogue Number: 8229707
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/15/2017
• Supplement Date Received by Manufacturer: 02/15/2017
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 10/02/2017
• 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