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

Model Number	977006
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Codes	Device Overstimulation of Tissue (1991); Pain (1994); Insufficient Information (4580)
Date of Event	09/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with an implanted neurostimulator and leads experienced new sacroiliac-area pain unrelated to baseline pain, pain at the neurostimulator/battery site, and an abrasive sensation around the battery site.During reprogramming on (b)(6)2026, the patient reported leg heaviness, suspected high stimulation, and requested stimulation adjustment.The abrasive sensation had been present immediately before reprogramming.Device impedance testing was optimal, no signs of overstimulation were observed, and programming adjustments were made.The patient later reported that the leg heaviness was part of the pre-implant pain.The patient attempted to lower the device settings and subsequently turned the device off; normal baseline pain returned with the device off, while the new sacroiliac-area pain and abrasive battery-site sensation persisted.The patient contacted the healthcare provider on (b)(6)2026 regarding recurrent pain and abrasive sensation.On (b)(6)2026, the physician advised the patient to return for sacroiliac- area epidural injections and further evaluation of the operative/implant site, planned for (b)(6)2026.No rash, redness, oozing, or other issues were reported.The pain and abrasive sensation were ongoing.  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.

• 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: 50840537
• Report Number: 3004209178-2026-15939
• Device Sequence Number: 9949740
• Product Code: LGW
• UDI-Device Identifier: 00763000964153
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 09/15/2026
• Initial Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 09/18/2025
• 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: 53 YR
• Patient Sex: Female