MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM-NEURO® PATIENT INTERFACE; STIMULATOR, ELECTRICAL, EVOKED RESPONSE

Model Number	8253410
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis of the device found that there was no fault.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 8253402, serial/lot #: (b)(6), ubd: , udi#: (b)(4) h3: product analysis for the product id: 8253402, serial/lot #: (b)(6) found that there was no fault.Additional code of img g02030 is applicable for product id: 8253402, serial/lot #: (b)(6).H4: manufacturing date for product id: 8253402, serial/lot #: (b)(6) is 15 october 2019.D1: brand name for product id: 8253402, serial/lot #: (b)(6) is nim-neuro® 3.0 mainframe.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that before operation, the nim 3.0 patient interface had a test failed.There was no patient involved.
Event or Problem Description
As per the additional information received, the customer had latency and amplitude mismatch issues.These readings and graph can be seen on screen which is a visual indicator that alerts the user of this issue.And the procedure was completed using back-up product which makes the event not reportable.
Additional Manufacturer Narrative
Additional information received stating that, in facial nerve monitoring, the latency and amplitude monitoring channels did not match, and the device failed to self-check.These readings and graph can be seen on screen which is a visual indicator that alerts the user of this issue.And the procedure was completed using back-up product.Above information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event does not meet the reporting requirements in 21 cfr 803.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: NIM-NEURO® PATIENT INTERFACE
• Common Device Name: STIMULATOR, ELECTRICAL, EVOKED RESPONSE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: glen belmer ; 6743 southpoint drive north; jacksonville, FL 32216 ; 6122713209
• MDR Report Key: 19333011
• Report Number: 1045254-2024-00736
• Device Sequence Number: 6816356
• Product Code: GWF
• UDI-Device Identifier: 00643169782464
• UDI-Public: 00643169782464
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K083124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

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: 8253410
• Device Catalogue Number: 8253410
• Device Lot Number: 218544843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown