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	Intermittent Continuity (1121); High impedance (1291)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	04/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a manufacturer's representative (rep) regarding an implantable neurostimulator.The rep reported that the patient (pt) had an older lead and extension since 2008 and since the pt's battery replacement in (b)(6) 2026.Then, rep noticed the pt had all elevated impedances on the cervical lead, the 3778 lead, and the healthcare provider (hcp) decided to surgically replace the lead in (b)(6) 2026.When the healthcare provider (hcp) tested the lead inter-op, the lead impedances were fine and came back within range, so lead was never replaced.Pt complained of a lack of coverage, so rep had been reprogramming patient.Now, however, pt had adequate coverage, but pt said they had been getting "spikes in stimulation" that were annoying and not consistent based on position or the group the pt was in.Pt would be sitting and the stimulation would ramp up to a high level where it got uncomfortable and then go back down.Pt said the spikes were random and not associated with a certain position and happened in several positions randomly.The rep checked impedances on both leads and said the impedance values were fine, but one of the impedances was a little high on the cervical lead.The rep did not understand why they were getting spikes in stimulation.Pt had 1 program for their cervical lead and a second program for the lumbar lead.Agent suggested trying to play around with rate to see if balance could be achieved between coverage without spikes.Tss also suggested running positional impedance testing to see if impedance values significantly changed.Additional information was received from the manufacturer representative (rep).The rep clarified that in april, the patient (pt) underwent a battery replacement.During the replacement, the cervical lead had bad connections despite trouble shooting therefore the lead was not functioning at all.This resulted in a lead revision in (b)(6) 2026.Once the leads were wiped, connections were good and no lead replacement was needed.It was not until then that they pt expressed changes in coverage.Stimulation spikes were reports august 25, 2026.The one high impedance had been present for years.The rep stated reprogramming and a lead revision would be done if required.Additional information was received from the manufacturer representative (rep).The rep stated they were present at the lead revision on (b)(6) 2026.The rep stated that as of now, the patient (pt) and healthcare provider (hcp) want to continue reprogramming to see if the issue could be resolved.If they cannot resolve the issue with reprogramming, the pt may consider a lead revision.
Additional Manufacturer Narrative
Continuation of d10: product id 3778-60 lot# serial# (b)(6).Implanted: (b)(6) 2008.Explanted: product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 3778-60, serial/lot #: (b)(6), ubd: 02-jul-2012, udi#: (b)(4).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: 50805305
• Report Number: 3004209178-2026-15772
• Device Sequence Number: 20993655
• Product Code: LGW
• UDI-Device Identifier: 00763000984656
• UDI-Public: (01)00763000984656(17)280228(20)01
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/17/2026

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: 04/22/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 03/02/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "See H11...."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female