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); High impedance (1291); Energy Output Problem (1431)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented with an inability to adjust groups on the remote and feeling tonic stimulation.An impedance check was performed and identified high impedance on multiple contacts, with contacts 1, 2, 4, 8, and 10 documented at 40,000, and multiple contacts marked as ¿avoid,¿ including contacts 1, 2, 4, 8, 10, and contact 0.Programming was performed around the high impedances, after which the patient reported great coverage.The ability to make necessary adjustments on the remote was double-checked and adjustments were able to be made.The issue was reported as resolved, and no patient injury or adverse outcome was reported.The manufacturer representative (rep) indicated they would send any further information as they become aware.
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: 25503652
• Report Number: 3004209178-2026-10016
• Device Sequence Number: 10520581
• Product Code: LGW
• UDI-Device Identifier: 00763000558826
• UDI-Public: (01)00763000558826(17)260428
• Combination Product (Y/N): N
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2026

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: 04/28/2026
• 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: 06/10/2026
• Initial Report FDA Received Date: 06/15/2026
• Date Device Manufactured: 05/07/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female