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

Model Number	8253001RF
Medical Device Problem Codes	Computer Software Problem (1112); Intermittent Continuity (1121); Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis found that the bezel was bent and touching the touchscreen caused by a shrunk gasket.(b)(4).Other relevant device(s) are: product id: 8253200rf, serial/lot #: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported that the mainframe has screen display issue and worked intermittently.The touchscreen was freezing during boot-up and nerve monitoring device crashes during surgery.This has happened multiple times.There was no patient impact.
Additional Manufacturer Narrative
For the interface device: analysis found that the customer's complaint could not be verified.The wave washer was worn and cable clip was broke.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: 8039383
• Report Number: 1045254-2018-00563
• Device Sequence Number: 1262792
• Product Code: ETN
• UDI-Device Identifier: 00643169871014
• UDI-Public: 00643169871014
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 03/14/2019

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: 214433838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 03/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1