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

Model Number	977006
Medical Device Problem Codes	Unintended Collision (1429); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Discomfort (2330); Ambulation or Postural Difficulties (2544); Electric Shock (2554); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id: 977a260, lot#serial#: (b)(6), implanted: on (b)(6) 2026, product type: lead, product id: 977a260, lot#serial#: (b)(6), implanted: on (b)(6) 2026, product type: lead.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 a patient experienced an electrical shock sensation radiating through the right arm following a fall.The sensation was uncomfortable enough that the patient turned off stimulation.There was a suspicion of possible lead migration, pending imaging confirmation.Outpatient cervical x-rays were ordered to assess lead positioning, and an impedance check was conducted, which was within normal limits.New programming was provided to recapture the right armpit and the area from the right shoulder to the elbow without the previously uncomfortable stimulation.The patient was scheduled to complete x-rays and follow up with the managing physician for additional reprogramming as needed.The issue was ongoing, and the patient remained alive with no injury.The manufacturer representative (rep) indicated they would send any further information as they become aware.Additional information was received f rom the manufacturer representative (rep) stating the patient had x-rays completed on (b)(6) 2026.There was no notable lead migration that would warrant a surgical revision and that the leads actually appear to be more midline that initial implant x-ray.The patient is still reporting a "zapping" sensation in her right arm even when the device is turned off.With agreement from the physician, the patient was advised to leave the device turned off for one full week.When they turn the device back on, they will have her cycle through her current programs at lower amplitudes to see if she notices improvement.They will then see the patient back in office at her 1 month follow up appointment to possibly reprogram and discuss other possible causes of her discomfort.

• 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: 24665219
• Report Number: 3004209178-2026-05163
• Device Sequence Number: 5055415
• Product Code: LGW
• UDI-Device Identifier: 00763000849078
• UDI-Public: (01)00763000849078(17)270314
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 05/13/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 05/13/2026
• Date Device Manufactured: 03/18/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11."
• Patient Age: 49 YR
• Patient Sex: Female