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

Model Number	8253402
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Failure to Power Up (1476); Use of Device Problem (1670)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/26/2018
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 via a distributor that the fuses of the device burned during the procedure, after replacing the fuses of the device with original fuses, the device was still not working.There was no patient involvement.
Additional Manufacturer Narrative
Analysis found that the fuses were not situated properly into the fuse box.The fuses was situated correctly.The box was replaced.The device was successfully tested according to service repair instructions.(b)(4) no longer apply.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
On follow up, it was confirmed that during a thyroidectomy procedure, the device did not turn on not starting or no power.The hcp also noted that the device was connected normally to a power supply plug inside the operating theater.There was no procedure delay and a back up device was used.

• Brand Name: NIM-NEURO® 3.0 MAINFRAME
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8054475
• Report Number: 1045254-2018-00575
• Device Sequence Number: 1696993
• Product Code: ETN
• UDI-Device Identifier: 00643169230378
• UDI-Public: 00643169230378
• Combination Product (Y/N): N
• PMA/510(K) Number: K083124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2019

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: 8253402
• Device Catalogue Number: 8253402
• Device Lot Number: 209562951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 12/03/2018; 02/25/2019
• Initial Report FDA Received Date: 11/09/2018
• Supplement Report FDA Received Date: 12/28/2018; 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1