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

Model Number	977118
Medical Device Problem Codes	Failure to Deliver Energy (1211); Energy Output Problem (1431)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from patient (pt) regarding an implantable neurostimulator (ins) it was reported that their handset was showing 50% and the implantable neurostimulator (ins) will be dead.Patient explained their issue vaguely.Patient stated that the ins will stop giving stimulation when it was at 50%.Patient said that that did not happen often but periodically.Patient tried connecting to mystim app and saw ins at 70% and communicator at 10%.The patient then tried charging the ins and was able to charge fine.Patient added that they slept and woke up it was at 30%.Patient mentioned that they had an appointment with their healthcare provider (hcp) and manufacturer representative (rep) because they cannot go above 12 on the intensity.Patient stated that they watch their device, and they saw that the stimulation goes off at 50% battery level.When asked if it's handset charge, they did not respond.Agent reviewed information and redirected to hcp to further address the concern.
Additional Manufacturer Narrative
B3: event date is not known.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 Pro
• 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: 50852934
• Report Number: 3004209178-2026-16003
• Device Sequence Number: 9953347
• 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): 09/22/2026

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: 09/16/2026
• Initial Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 04/09/2026
• 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 Sex: Female