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

Model Number	8227411
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/29/2019
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) via manufacturer representative reported that there was no emg response after stimulation, the electrode had difficulty identifying the nerve during the procedure.There was no known patient impact.
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received from rep stating that there was no emg response when stimulating the facial nerve.The electrodes have been changed 3 times then it worked.The impedance test was ok and the test with the patient simulator was ok.There was no patient impact.

• 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: 8558062
• Report Number: 1045254-2019-00214
• Device Sequence Number: 2372304
• Product Code: GXZ
• UDI-Device Identifier: 00643169290013
• UDI-Public: 00643169290013
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2019

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: 04/16/2022
• Device Model Number: 8227411
• Device Catalogue Number: 8227411
• Device Lot Number: 0215282981
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1