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

Model Number	977006
Medical Device Problem Codes	High impedance (1291); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient with an implanted neurostimulator (ins).It was reported that the lead was implanted and remained in service.There was no patient involved.During implant it was noticed that contact 2 showed damage.When physician connected lead to battery, connection and impedances were checked.Contact 2 showed connection issue and high impedance.Physician was made aware.Physician decided to close and move forward.Physician wiped leads clean.Lead was placed into ins and physician wrench to tighten lead.An additional connectivity check and impedance check were performed.Contact 2 showed connection issue and high impedance.Physician informed again.Physician decided to close and move forward.Hcp's had difficulty getting lead into epidural space due to patient anatomy.Additional information was received from a manufacturer representative (rep).The rep reported that the outcome will be more clear at first post op appointment when an impedance check can be done to see if it's cleared.Patient was doing well in post op immediately following the procedure and was able to be mapped around the impedance.
Additional Manufacturer Narrative
Continuation of d10: product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2026 explanted: product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(6), ubd: 17-may-2030, udi#: (b)(4) 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: 50818398
• Report Number: 3004209178-2026-15842
• Device Sequence Number: 21385024
• Product Code: LGW
• UDI-Device Identifier: 00763000964153
• UDI-Public: (01)00763000964153(17)280614
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• 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?: 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: 08/31/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 06/15/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "See H11...."
• Patient Sex: Female