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

Model Number	8253001
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received.Results are pending completion of the product analysis.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during a thyroid procedure, the user was not getting a response from the nim 3.0 device when touching the nerve.Requests for additional information have been made with no additional information provided at this time.There was no patient injury.
Additional Manufacturer Narrative
Date manufacturer received: january 23, 2017.The product analysis indicates that the reported issue could not be duplicated.There was no fault found with the device.As a precautionary measure, the device was placed in burn-in for 24 hours attempting to observe any failure.The device did not fail.It was tested and passed all manufacturing specifications.(b)(4).
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 6271016
• Report Number: 1045254-2017-00039
• Device Sequence Number: 50293
• Product Code: ETN
• UDI-Device Identifier: 00643169547049
• UDI-Public: 00643169547049
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup,Followup
• Report Date (Section B): 12/28/2016

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: 8253001
• Device Catalogue Number: 8253001
• Device Lot Number: 211883345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Initial Date Received by Manufacturer: 12/28/2016
• Supplement Date Received by Manufacturer: Not provided; 01/23/2017
• Initial Report FDA Received Date: 01/23/2017
• Supplement Report FDA Received Date: 02/15/2017; 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1