MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA SENSIGHT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number	B3400060
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Shaking/Tremors (2515)
Date of Event	08/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that a patient with deep brain stimulation therapy experienced a sudden return of tremor.Out of range (high) impedance was detected at contact 1b, which was a therapeutic contact, and the impedance issue was isolated to the left extension.The cause of the issue was not determined.Therapy could not be optimized despite reprogramming contact 1b.Both extensions were replaced and the issue resolved.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis (b)(4): analysis identified that the 1b conductor was broken in the body of the extension, 8.5 cm from the proximal end.Continuation of d10: product id b3400060m lot# serial# (b)(6) implanted: (b)(6) 2023 explanted: (b)(6) 2025 product type extension product id neu_ins_stimulator lot# serial# unknown implanted: explanted: product type implantable neurostimulator.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: SENSIGHT
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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 ; 7635265677
• MDR Report Key: 23427112
• Report Number: 2649622-2025-30518
• Device Sequence Number: 9798629
• Product Code: MHY
• UDI-Device Identifier: 00763000426477
• UDI-Public: (01)00763000426477(17)240924
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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: 09/24/2024
• Device Model Number: B3400060
• Device Catalogue Number: B3400060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2022
• 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 Sex: Male