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); Electromagnetic Compatibility Problem (2927); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with a pain stimulation implantable pulse generator (ipg) contacted support about issues with the spinal cord stimulator communicator, including rapid battery drain, poor charging performance, and erratic battery level indications.The patient stated the communicator battery dropped from 75% to 15% by the next day, and that after being plugged in for several hours the charge increased only from 15% to 45%, followed by unexpected jumps in the displayed battery percentage from 45% to 75% and then to 100%.The patient also reported that the communicator decreased from 100% to 90% while not in use.The patient stated they had received multiple communicator replacements, describing three communicators over three years and two replacement communicators already.The patient reported that when stimulation was on they could not lie flat and that stimulation ¿went nuts¿ when lying flat, and they reported turning stimulation off at night due to this.The patient expressed concern that if the communicator battery died at night, they would be unable to turn stimulation off and would be unable to lie down.The patient reported interference between deep brain stimulation equipment and the spinal cord stimulator system, stating that when the deep brain stimulation equipment was nearby it interfered with pairing and prevented the spinal cord stimulator devices from connecting to the implantable neurostimulator, and that the deep brain stimulation devices had to be kept approximately 25¿30 feet away.The patient stated they still had deep brain stimulation equipment from a system that had been removed and planned to try using the deep brain stimulation communicator with the spinal cord stimulator system.The patient reported back pain and stated they were scheduled for si injections for a hip condition.
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: 50071797
• Report Number: 3004209178-2026-12698
• Device Sequence Number: 21422837
• Product Code: LGW
• UDI-Device Identifier: 00763000411923
• UDI-Public: (01)00763000411923(17)250528
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 07/29/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2025
• 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: 07/09/2026
• Initial Report FDA Received Date: 07/29/2026
• Date Device Manufactured: 05/31/2023
• 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: Male