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

Model Number	NWCPU
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not marketed in the us; similar device available.The device has not been returned for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The device return indicated for an alleged malfunction, specifics were not provided.

• Brand Name: NIM-ECLIPSE® DESKTOP COMPUTER
• Common Device Name: STIMULATOR, ELECTRICAL, EVOKED RESPONSE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7105995
• Report Number: 1045254-2017-00453
• Device Sequence Number: 19226106
• Product Code: GWF
• UDI-Device Identifier: 00643169221000
• UDI-Public: 00643169221000
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 12/11/2017

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: NWCPU
• Device Catalogue Number: NWCPU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1