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

Model Number	8253200RF
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical devices: (b)(4) - nim mainframe response 3.0, serial # (b)(4), lot # 66456200, manufactured date ¿ feb/26/2010, 510(k) # k083124, udi # (b)(4).The nim patient interface (product # 8253200rf) was returned for analysis.Evaluation found that the device had a defective pcba and an incrementing probe failure.Evaluation also found that the unit came in with two incorrect fuses and had a missing o-ring.The device was repaired, missing items were installed, incorrected items were replaced, 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 intermittent failure.Evaluation found no fault with the device.The device was tested to manufacturer product specifications and returned to the customer.
Event or Problem Description
The facility reported that in two procedures, intra-operative the nim system was giving intermittent readings when it was "fired." the first procedure occurred on (b)(6) 2017 and the second procedure occurred on (b)(6) 2017.Both procedures were completed.There was no report of patient impact on both procedures.This regulatory report is being filed for procedure 1 of 2 that occurred on (b)(6) 2017 (medtronic internal reference number (b)(4)).Another regulatory report will be filed for procedure 2 of 2 that occurred on (b)(6) 2017 (medtronic internal reference number (b)(4)).

• 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: 6931765
• Report Number: 1045254-2017-00353
• Device Sequence Number: 633287
• 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): 09/14/2017

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: 71530900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 10/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1