MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number	97715
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from multiple sources regarding a patient implanted with a neurostimulator (ins).Lead migration/dislodgement and inadequate pain relief was reported.It was reported that the scs is not helpful and has been turned off.Met with a manufacture representative on 4/14/26 and was told that there were issues with their leads.Unable to do lead revision due to afib and recent placement of pacemaker.Patient reported that as far as they know, the device is not working even if they charge it.It charges and functions but it doesn't provide the therapy they need.Patient has not had the device checked out by the hcp for a while and do not plan to deal with the device as they had other unrelated health issues that they need a surgery for; patient confirmed the surgery was unrelated.Patient was asked about the lead issues and patient said they just told them that leads were not working.Patient doesn¿t remember if there was a manufacturer rep present there or not.This was about a year ago.Patient said the hcp has always been the same as the one who implanted the device but patient doesn¿t remember the name.Patient said as far as they remember, no one mentioned lead migration to them, they just said the lead was not working.Rep reported that the cause of lead issue/migration was unknown.Hcp will do a lead revision one the patient is able to hold her blood thinners for the procedure.Clinic will look into the guidelines from her cardiologist on how long she needs to remain on the blood thinners after her pacemaker implant.
Additional Manufacturer Narrative
Continuation of d10: product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2023 product type lead product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2023 product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(6), ubd: 10-nov-2026, udi#: (b)(4) ; product id: 977a260, serial/lot #: (b)(6), ubd: 21-nov-2026, udi#: (b)(4) 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: INTELLIS
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; +1(763)526-5677
• MDR Report Key: 50944782
• Report Number: 3004209178-2026-16579
• Device Sequence Number: 18547659
• Product Code: LGW
• UDI-Device Identifier: 00763000315467
• 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
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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 Expiration Date: 01/28/2024
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 02/07/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "See H11...."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female