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

Model Number	8227304
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 healthcare provider (hcp) reported that the monitor would not pick up signals from the electrode correctly.There was no known patient impact reported.

• 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: 8619242
• Report Number: 1045254-2019-00245
• Device Sequence Number: 16238551
• Product Code: GXZ
• UDI-Device Identifier: 20643169294374
• UDI-Public: 20643169294374
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K002992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2019

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 Model Number: 8227304
• Device Catalogue Number: 8227304
• Device Lot Number: 0213101085
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1