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

Model Number	97716
Medical Device Problem Codes	Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Distress (2329); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from patient (pt) regarding an external device.The reason for call was patient (pt) reported their controller was not working right, stating that it turned on but displayed a message and was described as ¿the power was no good.¿ pt stated their implant battery would not advance past 70% and confirmed that the controller battery was at 100%, while the implant remained at 70% all day.Pt also stated they attempted to charge their implant, but there was no progress.Pt stated spending 1 to 1.5 hours trying to figure it out and attempting to do so all morning.Pt mentioned previous calls.The pt expressed frustration, described the experience as horrible, and stated they had never had this much of a problem.Agent had pt reset the controller and blow air into the controller charging port.Pt confirmed no visible damage to the controller and battery pack.Agent called the pt back due to a poor connection but the pt hung up. patient called back stated they were very frustrated because they cannot get the ins to charge past 70-80% for couple weeks.Patient stated without the therapy they were in pain and they want to make sure the therapy was working and charging.Patient stated she charged the ins everyday.Patient stated they get excellent recharging quality and all of a sudden the ins will stop charging.Patient stated they get messages about charging the battery but they cannot recall what the messages were.Patient mentioned the recharger cord was replaced about 6 months ago.Patient did not have pain management physician patient asked to contact local manufacturer representative (rep). agent confirmed patient did not have a fall or trauma.Agent confirmed the controller was at 100%, ins 70% charged.Agent confirmed there was no visible damage on the recharger cord.Agent reviewed device function.Agent reviewed rep role and provided national answering service (nas) number for healthcare provider (hcp) office to call and patient disconnected the call.
Additional Manufacturer Narrative
B3: event date is not known.Please see b5 for approximate date range, if applicable.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: 50841580
• Report Number: 3004209178-2026-15954
• Device Sequence Number: 9949772
• Product Code: LGW
• UDI-Device Identifier: 00763000315474
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/21/2026

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: 03/28/2022
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 03/29/2021
• 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 Sex: Female