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); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Pain (1994); Sleep Dysfunction (2517)
Date of Event	06/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a patient regarding an external device.The reason for call was patient reported they had been having trouble with their device ever since they were first implanted with their current implant.Patient said they were supposed to be having an mri, but they could not get into the therapy app and communicator was not coming on.Agent asked, patient said they didn't know when they first got the issue, but the manufacturer representative (rep) told them that the device just kept going around in a circle and that's what it was doing now.Patient also said the communicator had an orange light on it and had been plugged in all night.Patient stated handset was circling on circling and connecting.Agent had patient plug communicator in to ac power supply and patient confirmed the light on communicator was solid green.Patient unplugged communicator from ac power and lights remained solid green.Patient reset communicator.Patient then attempted to connect to their therapy application, but reported communicator light was orange again.Patient plugged communicator back in and confirmed the green light came back on.Patient reset handset then reentered communicator serial number.Patient was then able to successfully enter mri mode.The troubleshooting steps that were taken on the call resolved the issue.Patient mentioned previously they had an issue with connecting cycling and sometimes it stopped at 60 on communication in progress screen.Additional information was received from the patient (pt).Pt called back and repeated the same issue that was previously documented.Agent had a hard time following pt's description.Pt stated they couldn't connect back to the therapy application after their mri.Pt noted they let the handset charge all night previously, and it showed to be at 94% or 91% during the call, but the communicator seemed to have rapidly discharged.Pt stated they would unplug the handset and suddenly be out of battery.Pt provided conflicting information throughout call regarding the battery charging/levels.Pt thought the communicator had a lso been fully charged as well, but did not confirm how they determined this.During the call, pt stated they would get to a screen that would get stuck spinning and spinning, and maybe would get as far as 60 before freezing.Pt stated they were currently on the spinning screen and 'ensure communicator is powered on' was displayed, along with the green and blue light of the communicator while plugged to ac power.When the communicator was disconnected, they saw an orange light flash then go out.Agent had pt disconnect from ac power to reset the communicator; from what pt said, agent thought the reset was successful and they reconnected to ac power.Pt stated the equipment did this same thing right when they got it and their "tech" said they'd have problems like this and directed the pt to the service department, but the pt thought they had things figured out on their own.Agent attempted to confirm if pt was recharging only the handset when they leave equipment plugged in at home; pt said they charge both devices, but seemed to think they were also a single/connected device.Before agent could have the pt close all apps and attempt connecting to their implantable ne urostimulator (ins) again, they were being called into an appointment with their doctor and had to disconnect.Patient will call back for further assistance.Additional information was received from a patient regarding an external device.The reason for call was patient stated the communicator is not connecting to the handset.Patient stated it had been working fine until friday night.Patient mentioned they have 3 different programs set on it but one is so that it is not so strong at night so they can sleep.Patient said they are on the strong one and they can't get it off because they cannot get it to communicate.Patient has been in pain all weekend and hasn't been able to sleep because they had this high thing on and every time they moved they were getting shocked down the leg.During the call patient service walked patient through resetting the communicator.The troubleshooting steps that were taken on the call resolved 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 ; +1(763)526-5677
• MDR Report Key: 50820703
• Report Number: 3004209178-2026-15871
• Device Sequence Number: 18811652
• Product Code: LGW
• UDI-Device Identifier: 00763000964153
• UDI-Public: (01)00763000964153(17)280428
• 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
• 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): 09/18/2026

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: 09/14/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 05/06/2026
• 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: 79 YR
• Patient Sex: Female