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); Communication or Transmission Problem (2896); Therapeutic or Diagnostic Output Failure (3023); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The reason for call was patient stated the spinal cord stimulator is not working.Patient said something about the internal battery needs to be replaced is what she sees.Agent asked when this started and patient said today and clarified a week ago.Patient then said it has been going off and stuff all the week this last week but now it is not work at all today.Agent walked patient through removing the battery pack and plugging controller into the ac power cord; patient confirmed controller powers on.Patient inserted the battery and confirmed controller is 100% and implant is 70%.Patient then connected recharger and confirmed charging excellent.Patient tried to turn stimulation on and was getting poor quality.Patient turned stimulation back on but said they are not feeling anything in their body.Pt states shes been seeing settings not available in each group she tries.Pt states just saw this monday.Agent reviewed code and stated this has to do with the ins and not equipment.Agent reviewed options to try over phone however directed to hcp to check ins and the settings not available.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.
Additional Manufacturer Narrative
B3: date is approximate.Month and year are 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 ; +1(763)526-5677
• MDR Report Key: 50820070
• Report Number: 3004209178-2026-15861
• Device Sequence Number: 10157815
• Product Code: LGW
• UDI-Device Identifier: 00763000315474
• UDI-Public: (01)00763000315474(17)240714
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 07/14/2024
• 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: 09/15/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 07/20/2023
• 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
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Unknown