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

Model Number	8253200RF
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical devices: (b)(4)- nim mainframe response 3.0, serial # (b)(4), lot # 66403800, manufactured date ¿ feb/25/2010, 510(k) # k083124, udi # (b)(4).The nim patient interface (product # 8253200rf) was returned for analysis.Evaluation could not duplicate the reported event of no stimulation response.Evaluation found that the device failed the triboelectric immunity test and the p/i board was loose on channel 2 port.The cable was replaced.The device was repaired, tested to manufacturer product specifications and returned to the customer.The nim mainframe response (product # 8253001) was returned for analysis.Evaluation could not duplicate reported event of no stimulation response.Evaluation found that the feet were missing on the device, the feet were replaced.The software was upgraded to current specifications.The device was tested with the p/i cable and it passed all manufacturing specifications.There was no functional fault found with the device.The device was tested to manufacturer product specifications and returned to the customer.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The facility reported that there was no stimulation response from the nim system.Biomedical engineer at the facility could not duplicate the issue of no stimulation response that was found during surgery.There was no patient impact.

• Brand Name: NIM® 3.0 INTERFACE
• Common Device Name: STIMULATOR, ELECTRICAL, EVOKED RESPONSE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 6943149
• Report Number: 1045254-2017-00361
• Device Sequence Number: 13665905
• Product Code: GWF
• UDI-Device Identifier: 00613994858399
• UDI-Public: 00613994858399
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K083124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Hospital Service Technician
• Type of Report: Initial
• Report Date (Section B): 09/15/2017

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: 69916500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1