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

Model Number	8253001RF
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results were not available as of the date of this report.A follow up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported that during the parotidectomy the mainframe had an excessive artifact even when the probe was not close to the nerve monitoring tube.For troubleshooting, the hcp tried to turn it off and on to reset however, the same issue occurred.There was a surgical delay as the hcp needed to stop and get a hand held nerve stimulator to complete the case after trying to trouble shoot.There was no patient impact.
Additional Manufacturer Narrative
Analysis found could not duplicate customer's complaint regarding excessive artifact.No fault found with the device.The device was cleaned, tested and passed all manufacturing specifications.(b)(4) no longer apply.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: 7956433
• Report Number: 1045254-2018-00495
• Device Sequence Number: 941523
• Product Code: ETN
• UDI-Device Identifier: 00643169871014
• UDI-Public: 00643169871014
• 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: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2018

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: 208682273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Supplement Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1