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

Model Number	8253001
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	07/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 during right parotidectomy with facial nerve monitor nim was not giving an audio tone when dissecting tissue around the parotid gland and trying to stimulate a nerve.The probe was also not giving back a tone when trying to locate the nerve and surrounding tissue of the parotid.The nurse said that there was nerve damage to the facial nerve on the patient and was giving a weak signal.Severity of the nerve damage was unknown.A stimulus probe was opened and plugged up to the console.Surgeon usually does not use probe that much, but relies on the other electrodes to "pick up" and sound alerts.The probe was used and did work once during the procedure while attempting to troubleshoot.Probe was not saved as we determined it was working fine.6 electrodes were used.The two in the orbicularis, 2 around the corner of the mouth, and the other two for grounding on the right shoulder.Approximately 2-3 hours after the completion of the procedure, surgeon updated that the patient was experiencing "facial nerve weaknes s." at the end of the day at approximately 2:00 pm, surgeon had updated that he thought the injury would actually improve, and may have been due to the 1% lidocaine injection administered during the procedure.The procedure was completed with another nerve monitor.There was less than one hour of surgical delay.Patient was alive with injury.
Additional Manufacturer Narrative
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® 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: 19947509
• Report Number: 1045254-2024-01226
• Device Sequence Number: 12544336
• Product Code: ETN
• UDI-Device Identifier: 00643169230385
• UDI-Public: 00643169230385
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K083124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8253001
• Device Catalogue Number: 8253001
• Device Lot Number: 209532918
• 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: 07/16/2024
• Supplement Date Received by Manufacturer: 11/10/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 11/10/2024
• Date Device Manufactured: 04/27/2015
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 20 YR
• Patient Sex: Male
• Patient Weight: 82 KG