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

Model Number	977118
Medical Device Problem Codes	Failure to Deliver Energy (1211); Unintended Collision (1429); Therapy Delivered to Incorrect Body Area (1508)
Health Effect - Clinical Codes	Distress (2329); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	04/24/2026
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 stated that their spinal cord stimulator just shut off all on its own.Patient stated that they got up this morning and everything was charged and both groups were shut off.Patient said that they went to start them up again and for both groups a, b, and c, the stimulation started running across their knees and they were not getting the relief in their back where it used to run across their back.When asked about any recent falls/trauma, patient mentioned that they had been under an extreme amount of stress and fell like 2 days ago when they took over their dog and fell severely jerked.Agent had the patient connect to the mystim app and patient was on group a with program 1 at 4.8 ma and program 2 at 5.3 ma.Patient noted that they could feel the stimulation in their thighs and knees and not so much in the back.Agent walked the patient through switching groups and patient confirmed that they were able to feel stimulation in group b, but in their thighs and knees not the back.Patient then switched to group c with program 1 at 5.4 ma and program 2 at 5.2 ma and felt the stimulation very little in the right leg.Agent reviewed role of manufacturer representative (rep).The issue was not resolved.The patient was redirected to their healthcare provider (hcp) to further address the issue.Patient mentioned they had their monthly meeting with their hcp yesterday.Patient mentioned they see their hcp next month along with rep.Patient then mentioned they were going out of town on may 2nd for 13 days.
Additional Manufacturer Narrative
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: 25027375
• Report Number: 3004209178-2026-07382
• Device Sequence Number: 14737599
• Product Code: LGW
• UDI-Device Identifier: 00763000558826
• UDI-Public: (01)00763000558826(17)250928
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 04/29/2026

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: 09/28/2025
• 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: 04/24/2026
• Initial Report FDA Received Date: 04/29/2026
• Date Device Manufactured: 09/30/2024
• 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: Female