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

Model Number	977006
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Codes	Paresthesia (4421); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that patient(pt)s communicator was no longer working as of tuesday.They spoke to the representative(rep) and they tried swapping out the cord but that did not work.Pt was vibrating on her back for two days (agent understood pt was experiencing stimulation).It was not a fun thing since pt was vibrating when trying to sleep.When pt was trying to use the communicator they got a message that said to turn commutator on but it would not turn on.During call caller closed all applications and powered off the handset.Caller held the communicator power button down for an extended period of time.Caller plugged the communicator into the charging cord and tried a different outlet, but communicator would not turn on or charge.The troubleshooting steps that were taken on the call resolved the issue.
Event or Problem Description
Patient representative called back and mentioned the new communicator was delivered.Patient rep mentioned they were trying to get it to work, there was no list of procedures provided with the unit and we think we got it right but they were unable to get it to connect.Agent instructed the patient rep to open the mystim app, patient confirmed a green and blue light on the communicator and handset prompted to use your handset to place the communicator over their implant.Agent instructed patient rep to place the communicator over their implant, patient rep confirmed handset showed device found and patient was able to connect to their therapy settings.Patient rep was able to turn the therapy on and patient confirmed they feel tingling in their back.Patient rep was able to adjust the stimulation to where patient was able to feel the stimulation.Agent reviewed with patient rep to close all applications in between use and to monitor.The troubleshooting steps taken on call resolved the issue.
Additional Manufacturer Narrative
Section b5 updated with additional information.Section h6 updated with additional codes.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 PAIN RELIEF
• 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: 24921772
• Report Number: 3004209178-2026-06769
• Device Sequence Number: 10063838
• Product Code: LGW
• UDI-Device Identifier: 00763000849078
• UDI-Public: (01)00763000849078(17)270328
• Combination Product (Y/N): N
• 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,Followup,Followup
• Report Date (Section B): 06/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 04/16/2026
• Supplement Date Received by Manufacturer: 04/20/2026; 05/26/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 04/22/2026; 06/04/2026
• Date Device Manufactured: 04/11/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Patient Age: 79 YR
• Patient Sex: Female