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

Model Number	977006
Medical Device Problem Codes	Energy Output Problem (1431); Data Problem (3196)
Health Effect - Clinical Codes	Device Overstimulation of Tissue (1991); Burning Sensation (2146); Insufficient Information (4580)
Date of Event	09/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was pt stating they have groups a, b, and c for their therapy and each group has 2 programs on it.Pt stated when they connect, it was turning on programs in another group.Pt stated they turn on therapy for groups c and then they go back to group a and that has turned on.Agent reviewed information about switching groups/changing intensity up and down.Pt then stated it felt like it 'it is pretty hot' and 'a bit much'.Pt stated this issue just started 'lately' and all of the sudden.Pt stated they feel like they were getting multiple therapies.Pt denied falls/trauma.Pt stated the healthcare provider (hcp)  usually refers them to manufacturer to run diagnostics.Pt stated this issue has not happened in the past.Pt will follow up with hcp to further address their concerns about the groups.
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.

• 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 ; +1(763)526-5677
• MDR Report Key: 50790274
• Report Number: 3004209178-2026-15686
• Device Sequence Number: 9524822
• Product Code: LGW
• UDI-Device Identifier: 00763000964153
• UDI-Public: (01)00763000964153(17)280114
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/16/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/16/2026
• Date Device Manufactured: 01/23/2026
• 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: 73 YR
• Patient Sex: Unknown