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

Model Number	97715
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was patient said that they will turn stimulation off but will feel stimulation still and said "its just one of the 4 program channels and when i do turn it back on, i go to turn the setting down and it says i cant lower it any more - even though its at 5.4v".Pt says if they turn stimulation off and then on again it will let them turn it down to zero.They said this originally started happening about a month ago.They said this seems to happen after they charge their implant.Pt said that last night they "started playing with their settings because it was doing weird stuff and they had to turn it off".The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.
Additional Manufacturer Narrative
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: 50915879
• Report Number: 3004209178-2026-16404
• Device Sequence Number: 14897608
• Product Code: LGW
• UDI-Device Identifier: 00763000315467
• UDI-Public: (01)00763000315467(17)221228
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 12/28/2022
• 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: 09/24/2026
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 01/13/2022
• 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 Age: 55 YR
• Patient Sex: Unknown