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

Model Number	97716
Medical Device Problem Codes	Intermittent Continuity (1121); Failure to Deliver Energy (1211)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 2026-feb-05 (b)(6) (con): information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was patient reported that they have been unable to feel any stimulation and experiencing pain since monday or tuesday of his week.Patient confirmed the stimulation is on.Patient stated that when the implant battery is at 100%, it typically lasts for more than one week.Patient confirmed controller battery at 50% and implant battery at 60%.Agent had the patient to check the programs they have.Patient mentioned having group a and b; current therapy group is set to group b.Agent walked the patient through adjusting stimulation intensity.Patient reported intensity was at 1.0; patient increased the intensity to 3.6 and reported feeling stimulation in back, lower back, hips, and legs.Patient stated they felt better after adjustment.Patient reported stimulation intensity returned to 1.0 and can't feel anything.Patient now reports feeling stimulation only in the back.The issue was not resolved.Agent redirected the patient to hcp for further assistance.
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.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 ; 7635265677
• MDR Report Key: 24292311
• Report Number: 3004209178-2026-02084
• Device Sequence Number: 15809120
• Product Code: LGW
• UDI-Device Identifier: 00643169781740
• UDI-Public: (01)00643169781740(17)211214
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 02/09/2026

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: 12/14/2021
• Device Model Number: 97716
• Device Catalogue Number: 97716
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 02/09/2026
• Date Device Manufactured: 12/16/2020
• 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: 68 YR
• Patient Sex: Female