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

Model Number	8253200RF
Medical Device Problem Codes	Unable to Obtain Readings (1516); Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis found that the customer's complaint was confirmed.The p/i board was replaced due to failure.The device was tested and passed all manufacturing specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported via distributor that the nerve monitor was not getting any stimulus, no stimulation response or not getting any positive/negative signals from the unit.The patient interface was still not working which just came from repair.The case was completed using another device.The console was working fine.They tested the interface and got nothing on the monitor (no stimulus sounds or signals).They switched the interface with a loaner interface and it seemed to operate fine.The console passed all safe test.

• Brand Name: NIM® 3.0 INTERFACE
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8055807
• Report Number: 1045254-2018-00581
• Device Sequence Number: 19152402
• Product Code: ETN
• UDI-Device Identifier: 00643169782501
• UDI-Public: 00643169782501
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K083124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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: 8253200RF
• Device Catalogue Number: 8253200RF
• Device Lot Number: 206797541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2018
• Initial 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