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

Model Number	8253001RF
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 has been updated.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.
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.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 while in thyroid mass surgery, the site was not receiving any response from the emg tube.Rep facetimed the site and saw that when thumping the neck to get mechanical response, the waveform was flat.The electrode check showed no issues.The site had tried increasing the stim and decreasing the threshold with no resolution.Swapped emg tube with no change.Unable to stimulate the nerve, however was able to get a stim response with probe, confirming the probe was working.Doctor was concerned for the preservation of the nerve, the nim gave no nerve response tone during case.Rep showed up at the end of the procedure and tried a second patient box.There was no change in outcome of response.There was a surgical delay of more than an hour.Thyroid was closed and patient moved to pacu.They used the prass probe to stimulate the nerve.The procedure was completed with nim, without nim/nerve confirmation.No therapy was given in pacu, patient was able to speak and swallow as per doctor.There was no patient injury.

• Brand Name: NIM® 3.0 MAINFRAME
• Common Device Name: STIMULATOR, NERVE
• 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: justin ellis ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635265677
• MDR Report Key: 21559419
• Report Number: 1045254-2025-00800
• Device Sequence Number: 14546630
• Product Code: ETN
• UDI-Device Identifier: 00643169871014
• UDI-Public: 00643169871014
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K083124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2025

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: 217428810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2023
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 03/10/2025
• Date Device Manufactured: 04/01/2019
• 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 Age: 42 YR
• Patient Sex: Male
• Patient Weight: 95 KG