MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SENSIGHT; Stimulator, thalamic, epilepsy, implanted

Model Number	B31030
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/17/2026
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 while pulling the tunneler from chest to skull pocket with dual extension carrier, there was significant bleeding from neck/extension tract to chest pocket.It was noted that the tunneling from skull to chest was difficult and tight.It was then noted that the pulling of tunneler with extension carrier and extension to skull from chest was difficult as well.Once, the extensions were pulled to the skull subgaleal pocket from the chest subclavicular pocket, bleeding wasnoticed coming from the extension neck tract to the chest pocket.The physician then had the resident hold pressure on neck to stop the bleeding while he had a gen surgery consult come into room to advise.He felt that the bleeding was venous in nature and would check back in 40 minutes to advise.The anesthesiologist then administered 350 mg.Txa for bleeding and compression was resumed on neck area.The duration of time for compression at this time was 10 minutes and pressure on neck was held for another 20 minutes after administration of first dose of txa.At the 30 minute mark, hcp advised that flo seal be pushed up tract from chest pocket and then pressure be resumed to neck.At about 40 minutes the gen surgeon came into the room and it was noted bleeding had lessened significantly.The anesthesiologist then administered a second dose of 350 mg.Txa and pressure on neck was resumed for 10 more minutes.At about an hour, pressure on neck was removed and it was noted that the bleeding had stopped.Hcp then instructed to close pocket andclose incisions.There was a tyrx pouch used for the device in pocket.The time of case was extended by at lead 1.5-2 hours due to difficulty with tunneler and complications caused by bleeding.The patient was originally booked for out-patient procedure and then changed to overnight observation due to this complication as well.

• Brand Name: SENSIGHT
• Common Device Name: Stimulator, thalamic, epilepsy, implanted
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 24639870
• Report Number: 3004209178-2026-04953
• Device Sequence Number: 15901875
• Product Code: MBX
• UDI-Device Identifier: 00763000426361
• UDI-Public: (01)00763000426361(17)271103(10)HG96BJG
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: B31030
• Device Catalogue Number: B31030
• Device Lot Number: HG96BJG
• 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: 03/17/2026
• Initial Report FDA Received Date: 03/19/2026
• Date Device Manufactured: 11/03/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 18 YR
• Patient Sex: Male