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

Model Number	977006
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	05/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a patient regarding an implanted neurostimulator (ins).It was reported that they are not having any back pain and the only pain they are having is where the ins battery is located.Caller stated this has been going on since the implant procedure and they expected to have pain after the procedure but are still experiencing it.Caller reported that if they lean on their back it causes serious pain.Caller said even when they are not leaning on their back they get random little pains that come that are kind of sharp.Caller stated they were told this is normal but they don't think it is.Caller also reported that the ins is not really providing them any help anyway and are considering having it explanted.Caller said the managing healthcare provider (hcp) ordered an mri because they think the leads may have moved and this may be why it is not helping with their pain at all.Caller reported that when they raise their hands in the air they feel the current going through their whole body and also feel this when they lie on their back.Caller expressed frustration regarding the active scan time limit for mri.Caller said they were not aware of this prior to having the ins placed and wish they would have told them beforehand so they could decide if they still wanted the ins implanted.Caller said they need mri every 6 months or once per year due to other conditions and was scheduled to have mri done on the 23rd.Caller was redirected to their managing hcp to further address the issue.
Additional Manufacturer Narrative
Section d references the main component of the system.Other medical products in use during the event include: brand name: lead; product id: neu_unknown_lead (serial: unknown); product type: 0200-lead.Due to the patient having multiple leads, it was unknown which one of the patient's leads had migrated:  brand name: vectris; product id: 977a260 (serial: (b)(6); implant date: on (b)(6) 2026; brand name: vectris; product id: 977a260 (serial: (b)(6); implant date: on (b)(6) 2026; brand name: vectris; product id: 977a260 (serial: (b)(6); implant date: on (b)(6) 2026.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: 50097530
• Report Number: 3004209178-2026-12771
• Device Sequence Number: 10479519
• Product Code: LGW
• UDI-Device Identifier: 00763000964153
• UDI-Public: (01)00763000964153(17)270828
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial
• Report Date (Section B): 07/31/2026

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 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: 07/29/2026
• Initial Report FDA Received Date: 07/31/2026
• Date Device Manufactured: 09/05/2025
• 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: 70 YR
• Patient Sex: Female