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

Model Number	8253001RF
Medical Device Problem Codes	Inappropriate Audible Prompt/Feedback (2280); Device Misassembled During Manufacturing /Shipping (2912); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during electrode and probe placement procedure, nim system became unresponsive, freezing and made excessive noise.Procedure was completed with reported products.There was no patient injury or impact.
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 8253200rf, serial/lot #: (b)(6), ubd: , udi#: (b)(4) h4: device mfg date: 05.12.2014 h6:fdm-b17 fdr-c20 fdc-d16 and img-g02005 codes are 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.
Event or Problem Description
Additional information received that user was able to monitor when it was not making noise.
Additional Manufacturer Narrative
H6: correction: fdd code of a110201 was not submitted in previous report.Previously applied fdc code d16 is no longer applicable.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 8253200rf, serial/lot #: (b)(6)/209031521, udi#: (b)(4).H6: correction: fdd code of a110201 was not submitted in previous report.Previously applied fdc code d16 is no longer applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant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: 19916437
• Report Number: 1045254-2024-01204
• Device Sequence Number: 7208165
• Product Code: ETN
• UDI-Device Identifier: 00643169871014
• UDI-Public: 00643169871014
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 09/03/2024

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: 8253001RF
• Device Catalogue Number: 8253001RF
• Device Lot Number: 207914269
• 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: 07/12/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 09/03/2024
• Date Device Manufactured: 01/14/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11....".
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 93 KG