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); Charging Problem (2892); Loss of Data (2903)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a patient's representative (pt rep) regarding external device.The reason for call was patient rep stated that the controller is off and they can't get it on and patient rep stated the issue started way four months ago.Agent instructed patient rep to check for visible damage; patient rep confirmed no visible damage to the recharger, controller compartment pins, controller port and li battery pack pins.Agent had patient rep reset the controller with ac power supply; patient rep confirmed controller powered on and a green blinking light was above the screen.Controller showed 50% recharging and implant 70%.Patient rep mentioned patient lost all of the programming.Patient rep pressed the therapy button then mentioned the controller showed no device found then connect the recharger.Agent instructed patient rep to start a charge session; implant was recharging with excellent quality.Agent walked patient rep through turning the stimulation on and patient rep confirmed the stimulation was now on.Later, pt rep called back stating the controller kept on saying stimulation off and they can't get the ins to recharge enough that they can use the stimulation for the patient.Pt rep stated that they reset the controller twice but that didn't resolve the issue.During the call pt rep had difficulty unlocking the controller screen using their finger even if they press the lock symbol firmly.Agent reviewed information.Agent had pt rep to unlock the controller screen using the white square button.Agent walked the patient rep to turn on stimulation and had them to recharge the ins.Pt rep confirmed that the group a showed a green highlighted color.Pt rep confirmed that they were able to charge the ins showed 70% and controller was at 50% with excellent connection.Pt rep said the ins battery level won't go up to 100% and been that way for some time.Agent reviewed recharging best practices.Agent instructed them to keep charging the ins and monitor the issue.Pt rep will call back if needed.
Additional Manufacturer Narrative
B3: date is approximate.Year is confirmed valid.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 ; 7635265677
• MDR Report Key: 24531888
• Report Number: 3004209178-2026-04127
• Device Sequence Number: 15720970
• Product Code: LGW
• UDI-Device Identifier: 00643169781740
• UDI-Public: (01)00643169781740(17)210728
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2026

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: 07/28/2021
• 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: 03/04/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2020
• 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
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male