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

Model Number	8253001
Medical Device Problem Codes	False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device was having issues with channel 3 and 4.Device should indicate non-nerve but will only display nerve when in use.This was confirmed by the ent rep.There was no patient impact.
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 8253200, serial/lot #: (b)(6), udi#: (b)(4), img code g02005.H3: analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.H4: manufacturing date for product id: 8253200, serial #: (b)(6) is 30.01.2017.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
H3:analysis found no fault with the device product id: 8253001 analysis for product id: 8253200, found worn wave washers.Broken screw boss in bottom housing.Could not confirm the customer's complaint.H6: previously submitted fdr code c0601 and fdc code d02 are applicable for product id: 8253200.Additional code img g02005 is no longer applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant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: 20436745
• Report Number: 1045254-2024-01775
• Device Sequence Number: 8405993
• Product Code: ETN
• UDI-Device Identifier: 00643169547049
• UDI-Public: 00643169547049
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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: 8253001
• Device Catalogue Number: 8253001
• Device Lot Number: 212471527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2016
• 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