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

Model Number	8253200RF
Medical Device Problem Code	Electrical Shorting (2926)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient interface (b)(6).The product analysis indicated the device cable required replacement due to failure.The cable was replaced.The device was repaired and tested to specifications.Nim mainframe 3.0 - (b)(4).Service did not find fault with the device.The device was tested to specification and returned to the customer.Concomitant device: (b)(4) ,nim mainframe 3.0, serial #(b)(4), lot # 69222500, 510k # k083124, udi # (b)(4).
Event or Problem Description
The customer reported they were unable to do any nerve stimulation or receive nerve feedback intraoperatively.There was no patient impact.

• Brand Name: NIM® 3.0 INTERFACE
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7062382
• Report Number: 1045254-2017-00428
• Device Sequence Number: 977611
• Product Code: ETN
• UDI-Device Identifier: 00643169782501
• UDI-Public: 00643169782501
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 11/27/2017

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: 8253200RF
• Device Catalogue Number: 8253200RF
• Device Lot Number: 71463100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 11/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1