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

Model Number	977118
Medical Device Problem Codes	Overheating of Device (1437); Charging Problem (2892)
Health Effect - Clinical Codes	Itching Sensation (1943); Burning Sensation (2146)
Date of Event	08/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Caller reports she was informed that her ins would last 1.5 days between charging, but she is needing to charge more frequently.Caller reports she would charge to 100% at night, the next morning, she needs to charge again.Caller reports she was informed never to let her ins battery level go below 40% caller reports she has increased her stimulation.Redirect caller to patient's hcp.Caller reports whenever she charges her implant, the first 20 minutes of charging, she feels warm and itching.Caller reports she has her sterile strips on currently, almost falls off.Caller reports sometimes she can stay the warm/itching and sometimes she has to stop and take a break.Caller reports she is using a thin material between charging redirect caller to patient's hcp.
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: 50867695
• Report Number: 3004209178-2026-16100
• Device Sequence Number: 15797632
• Product Code: LGW
• UDI-Device Identifier: 00763000984656
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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 Model Number: 977118
• Device Catalogue Number: 977118
• 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: 09/18/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 10/15/2025
• 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 Age: 42 YR
• Patient Sex: Female