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

Model Number	97716
Medical Device Problem Codes	Failure to Deliver Energy (1211); High impedance (1291); Low impedance (2285); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, following an incident unrelated to the implanted intellis pain neurostimulator in which the patient almost fell while exiting the shower but caught themself, the patient no longer felt stimulation and experienced return of pain and loss of pain relief.A low impedance or short issue was reported.Connection check showed red x indicators on electrodes 4, 5, 6, 7, 9, 12, and 13 and values greater than 40,000 with a possible open short involving lead electrodes 0 through 7 during a full in-pain check.The neurostimulator was reprogrammed.The issue was reported as resolved.The patient was alive with no injury.The manufacturer representative (rep) indicated they would send any further information as they become aware.
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: 50819013
• Report Number: 3004209178-2026-15848
• Device Sequence Number: 10677666
• Product Code: LGW
• UDI-Device Identifier: 00763000315474
• UDI-Public: (01)00763000315474(17)230928
• 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: 2023
• 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): 09/18/2026

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: 09/28/2023
• 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: 09/15/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 10/11/2022
• 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
• Patient Age: 57 YR
• Patient Sex: Female