MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM-ECLIPSE® CONTROLLER; STIMULATOR, ELECTRICAL, EVOKED RESPONSE

Model Number	ECLC
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, when running a tcemep the program on the computer read that the voltage was delivered but the current was much lower and no responses seen over muscles.After this, a stimulation no longer delivered any current at all (read out 0 on the machine).A new stimulator box and cord were both used, and the problem was not resolved.There was no patient impact associated with the event.
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.G4: please note that the involved device is not marketed in the united states; however, it is similar to the united states marketed device (945eclc).H3: product analysis found the fault is due to a loose usb port connection.Movement of the usb cable or even the controller will cause the controller to lose communication with the laptop.The tabs inside the usb port will eventually flatten due to constant inserting and removing of the usb cable.This will loosen the connection and cause the contact points between the cable and the port to shift or lose contact with one another.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: NIM-ECLIPSE® CONTROLLER
• Common Device Name: STIMULATOR, ELECTRICAL, EVOKED RESPONSE
• 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 ; 7635265677
• MDR Report Key: 21466325
• Report Number: 1045254-2025-00609
• Device Sequence Number: 21020346
• Product Code: GWF
• UDI-Device Identifier: 00643169378469
• UDI-Public: 00643169378469
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2025

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: ECLC
• Device Catalogue Number: ECLC
• Device Lot Number: 209369150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown