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

Model Number	8227411
Medical Device Problem Codes	Failure to Sense (1559); Low impedance (2285)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2018
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 distributor reported that the device had a short circuit during the operation and the nerve could not be tested during the operation but was able to be used after the replacement.It was noted that there were no patient symptoms or complications associated with the event.
Additional Manufacturer Narrative
Analysis of the returned device indicated that visually, there was no damage or anomalies in the construction of the device that would have resulted in the reported event.The green electrode end to end ohms resistance shall be less than 2.5 ohms; the actual measurements was 1.2 ohms indicating an in-specification condition.The paired electrode packages were opened for further analysis.The resistance between paired electrode cables shall measure less than 2.0 ohms and the actual measurements were; both pole of the red and blue = 1.8 ohms, both poles of the orange and violet = 1.4 ohms; there were no short circuits; all measurements were within tolerance.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.
Additional Manufacturer Narrative
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: 7605867
• Report Number: 1045254-2018-00249
• Device Sequence Number: 19256346
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

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: 08/20/2021
• Device Model Number: 8227411
• Device Catalogue Number: 8227411
• Device Lot Number: 0213878681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 06/21/2018; 08/08/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 07/18/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1