MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number	NEU_INS_STIMULATOR
Medical Device Problem Codes	Intermittent Continuity (1121); Energy Output Problem (1431); Therapeutic or Diagnostic Output Failure (3023); Data Problem (3196)
Health Effect - Clinical Codes	Pain (1994); Inadequate Pain Relief (2388); Insufficient Information (4580)
Date of Event	07/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins).It was reported that an "unusable setting value" message was displayed.All intensities for group a 1¿4 became 0.8, and even when the up arrow button was pressed, the "unusable setting value" issue occurred, preventing the intensity from being increased to the usual 1.4.Both the controller and ins were at 100%, and it was confirmed that adaptivestim was not used.There were groups b and c, but the patient did not change groups themselves and they were unaware of the reasons for the settings of each group.Group b had an intensity of 1.1 for all programs 1¿4, and group c had an intensity of 1.0 for all programs 1¿4.After switching groups and returning to group a, the patient attempted to lower the intensity of program 1 to 0.6 and then increase it, but an "unusable setting value" error occurred.While discussing the issue, the patient mentioned that the intensity dropped to 0.0, and they were unable to increase it due to the same error.For program 2 in group a, the intensity became 1.0 during the conversation, but the "unusable setting value" error prevented it from being increased.The cause of the sudden intensity changes could not be identified.Programs 3 and 4 remained at 0.8 without any changes.The patient experienced constant pain 24 hours a day and noted that the sensation of stimulation did not significantly vary regardless of the group or intensity.It was suggested to either leave the settings as they were and observe the issue, or wait for some time and try again.At the end of the conversation, the patient mentioned that their arm started feeling strange when the intensity of program 1 in group a dropped to 0.0.As a result, the group was switched to group b to monitor the situation.Details about what was strange with the arm could not be confirmed.The patient was advised to consult a medical institution if the situation did not improve through controller operation or if there were any health concerns.The issue was not resolved.No further information was available.
Additional Manufacturer Narrative
G2: the country of origin is japan.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: IMPLANTABLE NEUROSTIMULATOR
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22674042
• Report Number: 2182207-2025-01952
• Device Sequence Number: 3504046
• Product Code: LGW
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/31/2025

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: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2025
• Initial Report FDA Received Date: 07/31/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown