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

Model Number	8229975
Medical Device Problem Codes	No Display/Image (1183); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Extubate (2402)
Date of Event	09/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not marketed in the us; similar device available.Product evaluation: analysis results are not available; device not returned for evaluation.
Event or Problem Description
The physician reported that the emg tube ¿did not work, despite positive feedback on the verification screen.The patient had to be reintubated in the intervention court, (thus prolonging his intervention time, increasing his septic risk) and was very difficult to reintubate so he desaturated.It has been confirmed that there was no patient injury.Multiple attempts have been made to gain clarification of the event; however, at this time no additional information is available.
Additional Manufacturer Narrative
Product evaluation: 1 opened sample, part number 8229975, from lot number 0213242872, was received for analysis.As clarification, the ¿verification¿ screen may be referring to the monitoring screen however it is more likely it is in reference to the setup / electrode check screen.It is interpreted that the customer is most likely indicating that there is no stimulation or event tone even though the electrode check passed.Visually, 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 20cc of air; there was no obstruction of the inside diameter; no leaks; and the cuff would deflate with no issues.The drawing requires each circuit to be less than 20 ohms, and contain no short circuit between poles.The actual readings were as follows; red 18 ohms, red with band 19, blue 14 ohms, and blue with band 19 ohms.There were no short circuits or out of specification condition identified.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received confirming that ¿the breathing tube was repositioned several times: no positive results.All the connecting wires have been verified.Another breathing tube from another lot has been used¿ for reintubation and completion of procedure.¿ains [non-steroidal anti-inflammatories] were provided afterward.¿.

• Brand Name: NIM® EMG - ENDOTRACHEAL TUBE - NIM FLEX¿
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• MDR Report Key: 6941629
• Report Number: 1045254-2017-00357
• Device Sequence Number: 10942127
• Product Code: ETN
• UDI-Device Identifier: 20643169358816
• UDI-Public: 20643169358816
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2017

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 Expiration Date: 04/30/2021
• Device Model Number: 8229975
• Device Catalogue Number: 8229975
• Device Lot Number: 0213242872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 10/11/2017
• Supplement Report FDA Received Date: 12/11/2017
• Patient Sequence Number: 1