MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM® 3.0 MAINFRAME; STIMULATOR, NERVE

Model Number	8253001RF
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device(s) mainframe, patient interface, and the muting probe were returned and evaluated, no functional fault was found with the devices.Concomitant medical products: product # 8253200rf, product description patient interface, serial # (b)(4), lot # 212171821, manufacture date- october 20, 2016, 510(k) # k083124, udi # (b)(4), product # 8220325, product description muting probe, unknown.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported during testing the device is not reading esophageal stimulation.

• Brand Name: NIM® 3.0 MAINFRAME
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7100415
• Report Number: 1045254-2017-00450
• Device Sequence Number: 13648378
• Product Code: ETN
• UDI-Device Identifier: 00643169871014
• UDI-Public: 00643169871014
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K083124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/08/2017

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: 8253001RF
• Device Catalogue Number: 8253001RF
• Device Lot Number: 208282456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 12/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1