MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SENSIGHT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number	B32000
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id neu_unknown_lead (unknown); product type: 0200-lead; implant date (b)(6) 2026.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 design of the burr hole clip is not easy to secure.He struggles with getting it to engage in the ring.Because of the design, this is adding to the procedure's or time.He and his fellow/residents struggle with it.Today's case is an example of how the lead on the left was slightly pulled out when they had to struggle to secure the clip.They had to open the clip, push the lead back in, and then do a third scan to confirm correct placement.After the third ct scan, the lead did not move to the intended location.The final lead placement was not in the desired location.
Event or Problem Description
It was reported that the design of the burr hole clip is not easy to secure.He struggles with getting it to engage in the ring.Because of the design, this is adding to the procedure's or time.He and his fellow/residents struggle with it.Today's case is an example of how the lead on the left was slightly pulled out when they had to struggle to secure the clip.They had to open the clip, push the lead back in, and then do a third scan to confirm correct placement.After the third ct scan, the lead did not move to the intended location.The final lead placement was not in the desired location.Additional information received from rep indicating that hcp attributes poor design to device failure.
Additional Manufacturer Narrative
Continuation of d10: product id b3300542 lot# serial# (b)(6), implanted: (b)(6) 2026, product type lead.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 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: 24618303
• Report Number: 2182207-2026-00691
• Device Sequence Number: 9575854
• Product Code: MHY
• UDI-Device Identifier: 00763000426521
• UDI-Public: (01)00763000426521(17)271210(10)082M34425
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup
• Report Date (Section B): 03/25/2026

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: B32000
• Device Catalogue Number: B32000
• Device Lot Number: 082M34425
• 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: 03/16/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 03/25/2026
• Date Device Manufactured: 12/10/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."; SEE H11...
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 28 KG