MAUDE Adverse Event Report: Medtronic Puerto Rico Villalba VECTRIS SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number	977A260
Medical Device Problem Codes	Unintended Collision (1429); Overheating of Device (1437)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146); Sleep Dysfunction (2517)
Date of Event	05/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a patient (pt) with an implanted neurostimulator (ins).It was reported that they switched to a compet itor's product in 2020, but they were still using the medtronic leads and so they could not have a mri. pt said that the device was causing them pain, so they were told to turn the device off.Pt said that they had burning sensations from their left knee up to their thigh.Pt said that they were told to find another doctor to have the device removed.Pt said that they hadn't turned the competitor's device off until recently due to having extreme pain.Pt said that they told the competitor's manufacturer representative (rep) that the implantable neurostimulator (ins) needed to be removed.Pt said that if it came down to it, they would find someone to open up their back and remove the device and then they would end up in the er.Pt said that they could only sleep 3-4 hours a day.Pt said that they had a fall in october 2024, but they had no problems until about a month and a half ago.Agent redirected pt to hcp to further address.
Additional Manufacturer Narrative
Continuation of d10: product id: 977a260, (va0h3ed010); product type: 0200-lead; implant date (b)(6) 2014 ; explant date 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: VECTRIS SURESCAN
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): Medtronic Puerto Rico Villalba; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): Medtronic Puerto Rico Villalba; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; +1(763)526-5677
• MDR Report Key: 50260826
• Report Number: 2649622-2026-24032
• Device Sequence Number: 16014286
• Product Code: LGW
• UDI-Device Identifier: 00643169109391
• UDI-Public: (01)00643169109391(17)180310
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

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 Expiration Date: 03/10/2018
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• 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: 07/24/2026
• Initial Report FDA Received Date: 08/14/2026
• Date Device Manufactured: 03/10/2014
• 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: 57 YR
• Patient Sex: Male