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

Model Number	ECLC
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
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
It was reported that the device has inconsistent response.Although there were no neurological deficits in the patients and there was no factor affecting the system (anesthetic, setup, etc.), neurophysiological responses expected from patients could not be obtaine d in both surgeries.There were differences between the patient's neurological examination and the responses of the device.It was noted that the malfunction happened when using on patient (intra-operatively).For troubleshooting, the whole system was checked, but could not find what was wrong with the device.There was no patient impact.

• 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
• MDR Report Key: 11805575
• Report Number: 1045254-2021-00234
• Device Sequence Number: 3659541
• Product Code: GWF
• UDI-Device Identifier: 00613994910967
• UDI-Public: 00613994910967
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K061639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2021

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: NO INFORMATION
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1