MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM VITAL¿ CONSOLE; STIMULATOR, ELECTRICAL, EVOKED RESPONSE

Model Number NIM4CM01

Device Problems Computer Software Problem (1112); False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2023

Event Type  malfunction  

Event Description

It was reported that during the procedure nim vital did not react when nerve was stimulated.Also the keyboard was not showed up while entering reports.The device failed 5 times the self-test and the device was correctly set up but while stimulation there was no reaction on the monitor.Continued the procedure without nim vital and used a back-up product.There was no patient impact.

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: nim4cpb1, serial/lot #: (b)(6), udi#: (b)(4), h4: manufacturing date for product id: nim4cpb1, serial#: (b)(6) is (b)(6) 2023d1: brand name of the product id: nim4cpb1, serial#: (b)(6) is nim vital¿ patient interface 4 channel img code for product id: nim4cpb1, serial#: (b)(6) is g02005.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H3: product analysis of the device found that there was no fault identified.And reported could not be confirmed.Previously applied codes fdm b17 and fdr c20 are no longer applicable.H3: product analysis of the device with product id: nim4cpb1, serial/lot #: (b)(6)/227347692, found that there was no fault identified.And reported could not be confirmed.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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information received stating that the device failed 5 times the self-test and the device was correctly set up but while stimulation there was no reaction on the monitor.

• Brand Name: NIM VITAL¿ CONSOLE
• Type of Device: 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: 18476741
• MDR Text Key: 333009935
• Report Number: 1045254-2024-00062
• Device Sequence Number: 1
• Product Code: GWF
• UDI-Device Identifier: 00763000528577
• UDI-Public: 00763000528577
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K200759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NIM4CM01
• Device Catalogue Number: NIM4CM01
• Device Lot Number: 227398370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1