MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM EMG ELECTRODE; ELECTRODE, NEEDLE

Model Number	8227411
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2020
Type of Reportable Event	Malfunction
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 distributor that when the doctor used the probe to detect during a parotidectomy procedure, the nerve monitor did not respond.The doctor checked that the electrode check were displayed normally, and tried to use the patient simulator to find that both the nerve monitor and the patient interface were normal.So the doctor thought that the probe or the paired subdermal electrodes was defective.There was no delay in the procedure as a result of this event.The procedure was completed with the reported device.The patient was alive with no injury.Follow-up information confirmed that the electrode displayed normal on nim and the probe displayed the stim return was not zero.But there was no response on nim when the doctor detected the nerve.
Additional Manufacturer Narrative
H3: analysis found that visually, there was no external damage or anomalies in the construction of the device that would have resulted in the reported event.Note - the paired electrodes have a positive and negative side, the green ground and red/white stim return electrodes are a single pole.The green and red/white electrodes end to end ohms resistance shall be less than 2.5 ohms; the actual measurement was 1.2 ohms for the green and 1.0 ohms for red/white which is an in-specification condition.The resistance between paired electrode cables shall measure less than 2.0 ohms and the actual measurements were; the red poles measured (open to erratic when manipulating the strain relief) on one side and 1.6 ohms on the other; the blue poles measured 1.8 ohms and 1.5 ohms; the orange poles measured (open to erratic when manipulating the strain relief) on one side and 1.9 on the other; the violet poles both measured 1.9 on both sides; there were no short circuits; one of the red and one of the orange poles were out of specification.The analysis of the probe that was used in this same event showed discoloration, it was darker, which may indicate voltage was introduced that exceeded the devices intended use.The information most likely indicates the electrode resistance degraded due to abnormal electrical spikes during use.H6: fdm 4114, fdr 3221 and fdc 67 are no longer applicable.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
On follow-up, it was reported that there were no error codes displayed or any visual/audible indicator that alerted the user of the issue.The issue was not resolved by repositioning or troubleshooting.It was noted that it was the initial use of the electrode and probe.

• Brand Name: NIM EMG ELECTRODE
• Common Device Name: ELECTRODE, NEEDLE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 9956197
• Report Number: 1045254-2020-00232
• Device Sequence Number: 2437630
• Product Code: GXZ
• UDI-Device Identifier: 00643169290013
• UDI-Public: 00643169290013
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K002992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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: 06/23/2023
• Device Model Number: 8227411
• Device Catalogue Number: 8227411
• Device Lot Number: 0217962390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1