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

Model Number	977A275
Medical Device Problem Codes	Break (1069); High impedance (1291)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer representative (rep) reported that on (b)(6) 2024 the patient (pt) would be having their lead revised due to an issue with the lead.  the rep reported the lead contacts were no longer working and high impedances were measured.  the rep also reported the pt was no longer receiving pain relief and had a return of pain.As a result, the lead would be revised and they noted the implanted neurostimulator (ins) would be upgraded.  no further information was provided.Additional information was received from the rep on 2024-aug-19, they reported both leads were revised.It was reported to be unknown when the pt first noticed the loss of pain relief / return of pain.In response to potential contributing factors to this event, the rep stated the pt mentioned playing basketball.The rep reported the facility kept the explanted devices, they will not be returned for analysis at this time.
Additional Manufacturer Narrative
Continuation of d10: product id 977a275 lot# serial# (b)(6); implanted: (b)(6) 2023; explanted: (b)(6) 2024; product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 977a275, serial/lot #: (b)(6), ubd: 20-oct-2026, 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): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20020137
• Report Number: 2182207-2024-03568
• Device Sequence Number: 8674794
• Product Code: LGW
• UDI-Device Identifier: 00763000324285
• UDI-Public: 00763000324285
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/21/2024

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: 977A275
• Device Catalogue Number: 977A275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 08/21/2024
• Date Device Manufactured: 02/21/2023
• 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...."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male