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

Model Number	8253001RF
Medical Device Problem Codes	Use of Device Problem (1670); Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id: 8253200rf, serial/lot #: (b)(4), udi#: (b)(4).Analysis results for the mainframe were not available as of the date of this report.A follow-up report will be submitted when analysis is complete; analysis could not duplicate the issue with the patient interface, however, analysis found that the cable clip was loose.The wave washer was replaced and the device was tested and passed all manufacturing specifications.(b)(4) applies to the mainframe device; (b)(4) applies to the patient interface.
Event or Problem Description
A health care provider (hcp) reported via a manufacturer representative that the mainframe and patient interface had an interference/increased feedback during monitoring and were not functioning properly during the procedure.The surgeon did not want to troubleshoot to resolve the feedback since the procedure was almost finished, instead the surgeon requested to swap out the devices which would be quicker than trying to troubleshoot the device issue.The hcp noted that the continuous feedback sound was more annoying to the surgeon than a problem with the monitoring.There was just a short delay in the procedure while swapping out the devices.The case was completed with new system devices (mainframe and patient interface).There was no patient impact.
Additional Manufacturer Narrative
Analysis of the mainframe could not duplicate the customer's issue of increased feedback during monitoring and not functioning properly since there was no fault found with the device.As a precautionary measure, the device was placed in a burn-in for 4 hours to observe for any failure.The device never failed.The device was tested and passed all manufacturing specifications.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: 8096406
• Report Number: 1045254-2018-00642
• Device Sequence Number: 1988010
• Product Code: ETN
• UDI-Device Identifier: 00643169871014
• UDI-Public: 00643169871014
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 01/24/2019

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: 8253001RF
• Device Catalogue Number: 8253001RF
• Device Lot Number: 214086048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1