MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO.; Stimulator, spinal-cord, totally implanted for pain relief

Model Number	977118
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Pain (1994); Numbness (2415); Electric Shock (2554)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a patient regarding an implantable neurostimulator (ins).The reason for call was patient reported they can't make an adjustment to the program, their legs were numb and it had not been a good 24 hours.Patient mentioned they were so sore yesterday, they had to leave the rodeo earlier because they couldn't sit there and their legs had electricity buzzing down them.Patient stated that they were able to charge their implant last night at midnight.Patient noted that the handset was not syncing to the pancake and they couldn't bring the phone up to see if they could make adjustments into the programs they had in there.Patient mentioned that they had another stimulator was for their arms and that was the best thing they ever did for them and their arms worked perfectly.Patient noted the intellis pro was for their legs and the other implant was for their arms, but this implant had been a pain ever since they got it (agent understood patient was referring to their intellis pro implant).Patient was working with manufacturer representative (rep) to adjust the stimulator.Agent walked patient through resetting the communicator.Patient opened the mystim app, turned the communicator on, entered the code of the communicator manually and place the communicator over their implant.Patient then confirmed they were able to connect to their therapy settings, the implant was 100% and communicator 100%.Agent reviewed with patient to close all applications in between use and to monitor.The troubleshooting steps that were taken on the call resolved the issue.
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.

• Common Device Name: Stimulator, spinal-cord, totally implanted for pain relief
• 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: 25588557
• Report Number: 3004209178-2026-10486
• Device Sequence Number: 13333812
• Product Code: LGW
• UDI-Device Identifier: 00763000558826
• UDI-Public: (01)00763000558826(17)260728
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 06/22/2026

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: 07/28/2026
• Device Model Number: 977118
• Device Catalogue Number: 977118
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 06/22/2026
• Date Device Manufactured: 08/01/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Patient Age: 69 YR
• Patient Sex: Unknown