MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. SENSIGHT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number	B31000
Medical Device Problem Codes	Unstable (1667); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
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 the support clip of the burr hole device would not clip in or secure the lead prior to use.The surgeon attempted multiple times to secure the clip without success.The support clip was replaced with a new one and the issue resolved.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
H3.Analysis of the burr hole device (lot# 082t03825) found no anomalies.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 NAVIGATION, INC.; 200 medtronic drive; suite d; lafayette CO 30188
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; suite d; lafayette CO 30188
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 23086376
• Report Number: 3015531529-2025-00006
• Device Sequence Number: 10484521
• Product Code: MHY
• UDI-Device Identifier: 00763000426514
• UDI-Public: (01)00763000426514(17)270207(10)082T03825
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: B31000
• Device Catalogue Number: B31000
• Device Lot Number: 082T03825
• 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: 09/16/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male