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

Model Number	8227410
Medical Device Problem Codes	Use of Device Problem (1670); Noise, Audible (3273)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2018
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 manufacturer representative that the electrodes seemed to be faulty during right parotidectomy.The doctor said the machine was beeping irregularly.The surgeon disconnected the electrodes from the white box and plugged back in.When that did not work he removed the electrodes from the patient and applied a new ones which worked fine.There was 5 minutes delay.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: 8137033
• Report Number: 1045254-2018-00685
• Device Sequence Number: 16539824
• Product Code: GXZ
• UDI-Device Identifier: 00643169290006
• UDI-Public: 00643169290006
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K002992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2018

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: 06/16/2020
• Device Model Number: 8227410
• Device Catalogue Number: 8227410
• Device Lot Number: 0216432448
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 62