MAUDE Adverse Event Report: QUALITY TECH SERVICES LLC SENSIGHT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number	B32000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Cognitive Changes (2551)
Date of Event	04/04/2025
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 during a deep brain stimulation procedure, a brain bleed occurred intraoperatively.The patient experienced cognitive deficits post-operation, although the extent of these deficits is currently unknown.It was believed that a blood vessel was hit during microelectrode recordings, which contributed to the brain bleed.After burr holes were made and devices were placed, microelectrode recordings were performed, but no beneficial results were observed, leading to the decision to abort the case.Post-operative computed tomography confirmed the brain bleed.No surgical intervention was planned or occurred following the event.The device remains implanted and in service.It was unknown if there was any patient involvement or complications as a result of the event.
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
Additional information received from the manufacturing representative (rep).Rep reported that the cause of the bleed is still unknown, surgeon speculates that it occurred during the last mer pass, which it was the 5th or 6th mer pass on the hemisphere.Surgeon observed blood come up through the cannula after they took the microelectrode out on the last pass.This occurred before the leads were placed.Patient has the burrhole device with clip closed and capped off implanted.Surgeon may schedule another surgery later in the year.The patient stayed in the hospital for a week and it is unknown if surgery will be attempted again.

• Brand Name: SENSIGHT
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): QUALITY TECH SERVICES LLC; 7842 hickory flat highway; suite d; woodstock GA 30188
• Manufacturer (Section G): QUALITY TECH SERVICES LLC; 7842 hickory flat highway; suite d; woodstock GA 30188
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21915103
• Report Number: 3012165443-2025-00029
• Device Sequence Number: 20988412
• Product Code: MHY
• UDI-Device Identifier: 00763000426521
• UDI-Public: 00763000426521
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: B32000
• Device Catalogue Number: B32000
• Device Lot Number: 082M32424
• 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: 04/04/2025
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 05/26/2025
• Date Device Manufactured: 11/19/2024
• 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: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female