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

Model Number	977118
Medical Device Problem Codes	Intermittent Continuity (1121); Failure to Deliver Energy (1211); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a patient regarding an implantable neurostimulator.The reason for call was patient stated their stimulator was not working and they were hurting very bad since about wednesday last week.Patient's son then came on and confirmed stimulation was on and they had already tried changing stimulation.Caller said when the representative set up the programming, stimulation worked and stayed on and patient could slightly feel stimulation all the time.However, now after 10-20 minutes, the stimulation would shut itself off and they would have to go back to the handset and on the screen would turn the stimulation off and back on.Caller mentioned they had tried adjusting and changing programs already, but program 1 didn't do the patient any good anymore (even though it used to) and program 2 seems like it does ok, but also seems like stimulation would only stay on for like 10-20 minutes and then would shut off.The issue was not resolved.The patient was redirected to their healthcare provider to further address the iss ue.
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: 50898873
• Report Number: 3004209178-2026-16331
• Device Sequence Number: 5828961
• Product Code: LGW
• UDI-Device Identifier: 00763000984656
• UDI-Public: (01)00763000984656(17)280714(20)01
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 09/25/2026
• Date Device Manufactured: 07/15/2026
• 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: 73 YR
• Patient Sex: Female