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

Model Number NIM4CM01

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

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

Event Date 12/19/2023

Event Type  malfunction  

Event Description

It was reported that during thyroidectomy procedure vocalis 1 would pass electrode check, checked the position of the emg tube and rotated it slightly, then it passed the electrode test.The unit continued to failed the electrode test multiple times afterwards resulted in changing the emg tube 2 times with overall of 3 tubes being used without allowing vocalis 1 to pass consistently.The electrode would pass but the unit would not stimulate.It has been confirmed that it was on the vagas nerve visually and tried to stim and still had no result.The nim vital would not consistently pass the electrode check and would not stim even when it was positive to be on the nerve and could physically feel it.Switching of the emg tube 3 times, changing the probe, restarting the unit, changing the pi boxes.Ultimately, the nim unit had to be not used throughout the procedure.The procedure delayed by 60 minutes and completed using the reported products.There was no patient injury.

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s).Patient interface 4 channel additional code img g02005 is for product id: nim4cpb1, serial/lot #: unknown the report numbers for devices used in the same event are: 1045254-2024-00074 ,1045254-2024-00075, 1045254-2024-00076 and 1045254-2024-00077.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

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.

Event Description

Additional information received stating that the issue was not resolved even when switching of the emg tube 3 times, changing the probe, restarting the unit, changing the pi boxes.There was no patient injury.

• 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: 18504201
• MDR Text Key: 333336397
• Report Number: 1045254-2024-00078
• Device Sequence Number: 1
• Product Code: GWF
• UDI-Device Identifier: 00763000395896
• UDI-Public: 00763000395896
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• 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: 227125062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• Date Device Manufactured: 08/08/2023
• 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
• Treatment: "SEE H10."
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 61 KG