MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS¿; Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Model Number	977118
Medical Device Problem Codes	Charging Problem (2892); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/01/2026
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 pt reported experiencing pain which started about 10 days ago and had gotten worse for the last 5 days.They requested to have a manufacturer representative (rep) be present on their upcoming doctor's appointment.Pt mentioned that they've been in contact with their local rep over the weekend and the rep told them that they would contact another representative to meet them as they were not available.Agent reviewed the role of the rep and the national answering service number.The patient was redirected to their healthcare provider to further address the issue.Additional information was received from a manufacturer representative (rep).It was reported that the patient had a return of pain.The issue was not resolved and there were no actions taken to resolve the issue.The patient states that since their replacement, they are not getting relief even though exact programming that was previously working was programmed.The patient states the device is defective.Troubleshooting with the patient with programs continues and the rep encouraged them to utilize all programs.Additional information was received.It was reported that for a few months the patient's implantable neurostimulator (ins) was not in the right program so they were in pain.The patient was redirected to their healthcare provider to further address the issue.The patient had reached out to the rep saying they think there is something wrong with their battery because they can't charge without it beeping.The rep explained that it is important that the charger does not move.They also stated that it kicks them out of the app saying there is a recharge session happening.The rep had recently discussed with the patient that they can only use one app at a time.The patient called patient services (pss) to further troubleshoot.The patient also said they are getting an mri to determine if that's why the symptoms have worsened.The patient called into pss and reported having problems with their machine since it was not connecting to their device.The patient claimed they could not change their stimulator since it would freeze and go off displaying weird messages.The patient had met with their reps twice and they suggested the patient to call into patient services since they were in extreme pain.The patient claimed they got unable to connect and had taken pictures and videos of trying to connect but was getting not found.The patient also got a message that said active recharge charging and to turn off the wireless recharger - service code 338.The patient assumed they had to have the wireless recharger on when going to mystim app, agent reviewed how to use equipment.During the call, the patient was able to connect to mystim with no issues.The patient claimed that the wireless recharger might have been on when trying to connect to mystim prior to calling.The troubleshooting steps that were taken on the call resolved the issue.
Event or Problem Description
Additional information was received from a manufacturer representative (rep).It was reported that the rep was not aware of anything defective.The patient was not using the app correctly.The rep states its not helping with the patient's pain the way it used to and is being worked up with an mri.The rep stated that there was more teaching done with the handset and recharger.They are trying more programs and getting an mri.No mri has taken place yet.The rep stated they will reprogram if needed after the mri.The issue with the handset has been resolved.
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.
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 Pain Relief
• 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: 50786787
• Report Number: 3004209178-2026-15645
• Device Sequence Number: 15806566
• Product Code: LGW
• UDI-Device Identifier: 00763000984656
• UDI-Public: (01)00763000984656(17)271128(20)01
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: 09/11/2026
• Initial Report FDA Received Date: 09/16/2026
• Date Device Manufactured: 12/12/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "See H11...."
• Patient Age: 64 YR
• Patient Sex: Female