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

Model Number	8253200
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical product: 8253001 - nim mainframe response 3.0, serial # (b)(4), lot # 66456200, manufactured date ¿ feb/26/2010, 510(k) # k083124, (b)(4).The nim patient interface (product # 8253200) was returned for analysis.Evaluation found that the device has a worn wave washer, a cracked back enclosure and a scratched medtronic symbol.Analysis also indicated that the device came in with two missing o-rings and two missing spare fuses.The device was repaired, missing items were installed, tested to manufacturer product specifications and returned to the customer.The nim mainframe response (product # 8253001) was returned for analysis.Evaluation found that the unit came in with two missing feet and the device had a muting probe failure.The audio board was defective.The device was repaired, the software was upgraded to current specifications, tested to manufacturer product specifications and returned to the customer.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
The facility reported that intra-operative the nim system was giving an intermittent response.The system would respond sometimes and sometimes it would not.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: 6826183
• Report Number: 1045254-2017-00297
• Device Sequence Number: 10967391
• Product Code: GWF
• UDI-Device Identifier: 00613994858399
• UDI-Public: 00613994858399
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/03/2017

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: 8253200
• Device Catalogue Number: 8253200
• Device Lot Number: 66888400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2017
• Initial Report FDA Received Date: 08/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1