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

Model Number	NCCPU
Medical Device Problem Codes	Application Program Problem (2880); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned.Results pending completion of evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The device was returned from the customer as having an alleged defect.No specific information was provided.No patient injury or impact was reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from the customer, which indicates that preoperative, there was an issue with the software.They were unable to start the system.There was no patient involved.
Additional Manufacturer Narrative
The product analysis indicates the device was received in good condition and with the power supply.During start-up, the system was unable to connect to the system programs.The device needed reimaging and an upgrade to the latest version of software.At customer's request, the system was reimaged and upgraded to the latest available version of software in spanish.The system was successfully tested to specifications.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NIM-ECLIPSE® NOTEBOOK COMPUTER
• Common Device Name: STIMULATOR, ELECTRICAL, EVOKED RESPONSE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7025821
• Report Number: 1045254-2017-00405
• Device Sequence Number: 1345321
• Product Code: GWF
• UDI-Device Identifier: 00643169177710
• UDI-Public: 00643169177710
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2018

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 Model Number: NCCPU
• Device Catalogue Number: NCCPU
• Device Lot Number: 205941617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2017
• Supplement Date Received by Manufacturer: 11/13/2017; 12/19/2017
• Initial Report FDA Received Date: 11/13/2017
• Supplement Report FDA Received Date: 12/08/2017; 01/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1