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

Model Number	97725
Medical Device Problem Codes	High impedance (1291); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the rep wanted to inquire about an impedance issues observed with an scs lead during differential target multiplexed (dtm) programming.As shown in the provided image, when the lead was positioned in the middle line, they encountered impedance problems (per the provided images - electrodes 1-3, greater than 40000, then 1-6 greater than 40000, and then all electrodes greater than 40000).It was understood that 2 leads should be placed separately, but guidelines were requested on the required spacing.They were having trouble communicating this to their hcps, and having a base protocol with precise numerical guidance would be greatly helpful.As well, it was asked if there were any differences in recommended settings or procedures between external neurostimulators (wens) and implanted neurostimulators (ins) when performing dtm programming.The impedance interference usually only occurs during the trial phase and not after ins implantation.Training <(>&<)> education responded that there was no specific guidance on the minimum distance required between the two leads, however it was recommended that no electrodes be touching each other.In the images, it does appear that some of the electrodes between the two leads are touching.We would like to see a visual difference in spacing between the two leads.More impedance issues are seen with the wens than with inss due to the fact that they are inserting leads in the epidural space rather quickly during the trial and there is blood, tissue, scar tissue, fluid (things that can temporarily impede the electricity from penetrating the cord) present in the epidural space.Typically, the impedance issues are temporary and usually resolve within 24 hours or once the leads have had time to settle in.If you see that the impedance values are decreasing after some time than usually the issue is a temporary issue because of the factors above.
Additional Manufacturer Narrative
Continuation of d10: product id neu_unknown_lead lot# serial# unknown implanted: explanted: product type lead product id neu_unknown_lead lot# serial# unknown implanted: explanted: product type lead section d information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown, ubd: , udi#: ; product id: neu_unknown_lead, serial/lot #: unknown, ubd: , udi#: g2.Foreign: korea 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
Continuation of d10: product id 977d260 serial# (b)(6), product type screening device product id 977d260 serial# (b)(6), product type screening device 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 was received from a rep.It was reported that the issue appeared to have occurred during a dtm trial due to the spacing between the leads which resulted in abnormal impedance.The issue was resolved by placing the leads as far apart as possible, which seemed to have effectively addressed the problem.Additional information was received from a rep.It was reported that the issue occurred on (b)(6) 2024.The serial numbers of the wens and leads were provided.As it was a spinal cord stimulation trial, the leads were removed after the trial.They thought the issue was due to the leads touching.At the time, they tried to have wider space between the two leads several times.The impedance issue disappeared after several lead re-locations.It was noted that the hcp was already aware of this problem.

• Brand Name: INTELLIS
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21139156
• Report Number: 2182207-2025-00117
• Device Sequence Number: 7464771
• Product Code: LGW
• UDI-Device Identifier: 00763000689469
• UDI-Public: 00763000689469
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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 Expiration Date: 01/23/2026
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 06/25/2025
• Date Device Manufactured: 07/23/2024
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11."
• Patient Sex: Unknown