MAUDE Adverse Event Report: Medtronic Xomed Inc. ESSENCE EMG TUBE NIMEID080 5PK 8MM CE; STIMULATOR, NERVE

Model Number	NIMEID080
Medical Device Problem Codes	Difficult to Insert (1316); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/07/2026
Type of Reportable Event	Malfunction

• Brand Name: ESSENCE EMG TUBE NIMEID080 5PK 8MM CE
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): Medtronic Xomed Inc.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): Medtronic Xomed Inc.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: justin ellis ; 6743 southpoint drive north; jacksonville, FL 32216 ; +1(763)526-5677
• MDR Report Key: 50171153
• Report Number: 1045254-2026-01104
• Device Sequence Number: 8216472
• Product Code: ETN
• UDI-Device Identifier: 00763000821814
• UDI-Public: (01)00763000821814(17)280905(10)2025090036
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K251672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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: NIMEID080
• Device Catalogue Number: NIMEID080
• Device Lot Number: 2025090036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 08/07/2026
• Date Device Manufactured: 09/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown