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

Model Number	97716
Medical Device Problem Codes	High impedance (1291); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient treated with an implanted intellis pain neurostimulator system and two implanted mri-compatible leads for pain management experienced return of pain and inadequate pain relief while stimulation was on.The system had not been used for over one year before it was restarted, after which high impedance and out-of-range error messages were displayed on the handset.High impedance was not observed on the day of surgery, greater than 40,000.The patient reported no falls, slips, or trips and reported no injuries from a motor vehicle accident.Stimulation was turned off, and the healthcare provider was notified.The product issue remained ongoing.The manufacturer representative (rep) indicated they would send any further information as they become aware.
Additional Manufacturer Narrative
Continuation of d10: product id: 977a290; lot/serial#: (b)(6); implanted: (b)(6) 2024; product type: lead.Product id: 977a290; lot/serial#: (b)(6); implanted: (b)(6) 2024; product type: lead.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: 50869686
• Report Number: 3004209178-2026-16132
• Device Sequence Number: 21511588
• Product Code: LGW
• UDI-Device Identifier: 00763000315474
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 09/23/2026

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 Expiration Date: 09/28/2024
• Device Model Number: 97716
• Device Catalogue Number: 97716
• 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: 10/10/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "See H11...."
• Patient Age: 38 YR
• Patient Sex: Female