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

Model Number	8229970
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Apnea (1720)
Date of Event	04/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The completed analysis indicated that one opened sample of part number 8229970 from lot number 0213796223 was received.This lot was manufactured august 7, 2017.A portion of the flex circuit was cut off when received, which is typical for handling purposes when returning emg tubes and is not related to the complaint.A microscrope and syringe were used to analyze the sample.As it was received, there was no occlusion of the main tube inside diameter.There was no damage or anomalies in the construction of the device that would have resulted in the reported event.The cuff was inflated with 15cc of air, and pressure was applied to the cuff while viewing the inside diameter, which did not result in any delamination or occlusion.The tube was left inflated for one hour, and again, pressure was applied to the cuff with no delamination or occlusion.There was no out of specification condition identified as it relates to the complaint.¿ conclusion: there was no out of specification condition identified as it relates to the complaint.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The anesthesiologist reported that while the patient was intubated during a procedure, after an hour of being intubated, the nim emg tube herniated resulting in occlusion of the tube.The emg tube and cuff were checked prior to use.The cuff was inflated with approximately 8cc of air.The ventilator gave a pre-warning pressure alarm, even though tidal volume was acceptable.In less than one minute, complete occlusion of the tube was attended to and the patient was re-intubated with a new tube.The patient suffered severe apnea that was immediately reversed with establishment of the replacement tube.The patient's current status is stable; no injury has been reported.

• Brand Name: NIM® EMG - ENDOTRACHEAL TUBE - NIM FLEX¿
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7478507
• Report Number: 1045254-2018-00184
• Device Sequence Number: 11140546
• Product Code: ETN
• UDI-Device Identifier: 20643169358809
• UDI-Public: 20643169358809
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K925640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2018

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: 08/06/2021
• Device Model Number: 8229970
• Device Catalogue Number: 8229970
• Device Lot Number: 0213796223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 05/01/2018
• 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
• Patient Age: 20 YR
• Patient Weight: 70