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

Model Number	977006
Medical Device Problem Codes	Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Pain (1994); Electric Shock (2554)
Date of Event	06/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The pt reported pain/shock on the side where the spinal cord stimulator is located since yesterday.Pt noted they were having back pain and needed assistance to navigate.Pt mentioned the stim is on the left side but now the pain was on their right side.Agent instructed pt to connect to their therapy settings but the handset showed not found communicator.Agent walked pt through closing all applications and resetting the communicator.Pt then tried to connect to the mystim app and patient confirmed they were able to connect to their therapy settings.Pt was on group a at 1.0, agent walked pt through increasing the stimulation and pt confirmed they can't feel the stimulation.Agent asked and pt confirmed they only have group a.The pt was redirected to their healthcare provider to further address the issue.
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.

• Brand Name: VANTA
• 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 ; 7635265677
• MDR Report Key: 25435555
• Report Number: 3004209178-2026-09670
• Device Sequence Number: 16042065
• Product Code: LGW
• UDI-Device Identifier: 00763000849078
• UDI-Public: (01)00763000849078(17)270314
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2026

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 Model Number: 977006
• Device Catalogue Number: 977006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 06/08/2026
• Date Device Manufactured: 03/17/2025
• 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
• Patient Age: 84 YR
• Patient Sex: Female