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	12/13/2018
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 after all the electrodes were set for a parotidectomy procedure, the doctor confirmed that all electrodes on the monitor were checked.However, when the doctor did further testing by patting the patient's face, he found that there was no reaction from the nerves of chin, the purple electrode.The doctor tried to reset the electrode and checked all the connections, however there was still no reaction.Finally, the doctor used a different purple electrode to complete the surgery.The second purple electrode could function properly with the same mainframe.There was no error code displayed on the monitor.The hcp noted that it was the initial use of the electrode.The problem was noticed during testing, therefore there was no stim value since the doctor had not used the probe when the problem was noticed.The surgery was delayed for about 10 minutes.There was no patient impact or injury.
Additional Manufacturer Narrative
The resistance between needle and connecting pin shall measure less than 2.0 ohms and exhibit infinity between needles or connecting pins; analysis found that the actual measurements were - the violet / purple electrode poles measured 1.6 and 1.7 ohms, the orange poles measured 1.7 and 2.3 ohms and there was a short circuit between poles.The orange electrode was out of specification.Visually, there was no external damage to the plugs or wires which indicates internal damage.If information is provided in the future, a supplemental report will be issued.

• 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: 8245807
• Report Number: 1045254-2019-00024
• Device Sequence Number: 16591452
• 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,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2019

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: 01/18/2022
• Device Model Number: 8227411
• Device Catalogue Number: 8227411
• Device Lot Number: 0214752169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1