MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number	97715
Medical Device Problem Codes	Intermittent Continuity (1121); Battery Problem (2885)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the controller is not charging.Patient stated that this is the second time this has happened on a weekend and that they have been in pain all week.The patient stated that they plugged the controller in to the power supply in all week and performed a reset and they found looking for a device and no device found screen.Patient stated they were in pain all week and tried everything possible and the controller messes up on a weekend.(see previous cases).Patient also mentioned that the stimulation shut off.Patient stated they saw a message that the battery was low but handheld did not have enough power to charge the implant.Patient repeated handheld was not charging.Agent had the patient reset the controller with ac power supply.Patient confirmed no visible damage on the controller battery compartment pins and bp pins.Patient confirmed that the green light was flashing on the controller, but then the light stopped flashing.Patient then tried a different outlet and the controller screen powered on but then green light above the screen flashed and turned back off.Patient confirmed that there's green light on the ac power adapter.The issue was not resolved through troubleshooting.Agent submitted a request to the repair department to replace the ac power supply and battery pack.Patient mentioned they have a deep brain stimulator and only have to charge it once a week.Patient mentioned the issue began on friday.Pt called back escalated stating they're in pain since last thursday because he cannot charge controller and the ins.Pt states he told the past agent it was the controller that wasn't charging and we sent the battery and ac power.Agent sent request to repair for controller.Patient called back and got the software problem (1 intellis 2 3.6 3 245 4 ensinterfacesm.C) while attempting to charge the implant.During the call patient denied damages on the recharger and cleaned both the controller and recharger pins.Patient removed the battery and plugged the ac power.Controller powered on.Patient inserted the battery and green light displayed above the screen.Patient plugged the recharger and paired the controller to their implant.Controller was at 80% and implant was at orange and excellent.Patient mentioned they charged twice a day and charging took an hour.Patient was in so much pain due to the scs issue that they forgot to charge their dbs device.Patient charged the dbs device once a week and the dbs device didn't get lower than 50% and only took 20 minutes to charge the dbs device.Patient denied issues with the dbs device.Patient mentioned the scs implant battery drained faster.Agent reviewed information and redirected patient to their hcp.Agent closed case.
Additional Manufacturer Narrative
Serial# (b)(6), product type product id: 97745nt, serial# (b)(6), product type 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 NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21443289
• Report Number: 2182207-2025-00523
• Device Sequence Number: 7739953
• Product Code: LGW
• UDI-Device Identifier: 00763000315467
• UDI-Public: 00763000315467
• 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
• 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): 02/24/2025

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: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 02/24/2025
• Date Device Manufactured: 02/08/2023
• 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: 68 YR
• Patient Sex: Male