MAUDE Adverse Event Report: MPRI VECTRIS SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number	977A260
Medical Device Problem Codes	Unintended Collision (1429); Impedance Problem (2950)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was an impedance issue with the implantable neurostimulator and leads, specifically with electrodes 4 and 10, which were listed to avoid during an impedance check.Additionally, there was a loss of efficacy associated with the device.The cause of these issues was identified as a car accident.Troubleshooting was performed by programming around the impedance issue.It is unknown if the issue is resolved.
Additional Manufacturer Narrative
Continuation of d10: product id: 97715, serial# (b)(6), implanted: (b)(6) 2019, product type: implantable neurostimulator.Product id: 977a260, serial# (b)(6), implanted: (b)(6) 2019, product type: lead.Product id: 97715, serial# (b)(6), implanted: (b)(6) 2019, product type: implantable neurostimulator.Section d information references the main component of the system.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(6), ubd: 11-mar-2023, udi#:(b)(4) ; product id: 97715, serial/lot #: (b)(6), ubd: 28-jan-2020, 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: VECTRIS SURESCAN
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22035293
• Report Number: 2649622-2025-13413
• Device Sequence Number: 18346624
• Product Code: LGW
• UDI-Device Identifier: 00763000006501
• UDI-Public: 00763000006501
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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
• Report Date (Section B): 05/16/2025

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 Expiration Date: 03/11/2023
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 05/16/2025
• Date Device Manufactured: 03/11/2019
• 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 Age: 76 YR
• Patient Sex: Female
• Patient Weight: 82 KG