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

Model Number	8229980
Medical Device Problem Codes	Unable to Obtain Readings (1516); Use of Device Problem (1670)
Health Effect - Clinical Code	Extubate (2402)
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 the red circuit of the tube was not working during a thyroidectomy procedure.The hcp needed to remove the tube and re-intubate with another device.The patient was re-intubated, which did cause a delay and potential complication to patient; however, the case went well.The red circuit kept showing a cross when connected.The hcp tried the red lead in the blue socket and it showed a tick then swapped them over and showed a cross again proving it was the red lead that was faulty.There was a no "electrode off" showed at any time.
Additional Manufacturer Narrative
Analysis found that the customer indicated when the red circuit (of the tube) was plugged into the blue socket (patient interface), the circuit showed good; if the red circuit was bad, it would show bad regardless of where it was plugged into.The customer stated the (no "electrode off" showed at any time) which indicated there was high impedance rather than an open circuit.Changing from the red socket to the blue socket most likely changes the impedance and that was why it showed a ¿tick¿.Visually, the flex circuit contained wrinkles and creases which did not appear to be significant enough to have contributed to the reported event.There was no damage or anomalies in the construction of the device.The drawing requires each electrode circuit to be less than 20 ohms and contain no short circuits between poles.The actual readings were as follows; red 10 ohms, red with band 10 ohms, blue 14 ohms, and blue with band 12 ohms.There were no short circuits and no out of specification detected.The device came with a compatible, ground, and stimulation return electrode, which appeared to be unused.If information is provided in the future, a supplemental report will be issued.

• 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: 7820153
• Report Number: 1045254-2018-00393
• Device Sequence Number: 11371161
• Product Code: ETN
• UDI-Device Identifier: 20643169358823
• UDI-Public: 20643169358823
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2018

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: 07/04/2021
• Device Model Number: 8229980
• Device Catalogue Number: 8229980
• Device Lot Number: 0213594278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 10/19/2018
• 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