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

Model Number	B3301542M
Medical Device Problem Codes	High impedance (1291); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
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 lead was placed into cannula, lead test cable was attached, and we connected to lead with tablet.Hcp went to setup the tablet to perform connectivity and impedance check in order to do intraoperative testing, and on contact 2 (monopolar) and contact 2b there was impedance issues above 21k and the connectivity test failed.Neurosurgeon took lead test cable off distal portion of lead, reconnected and turned the cable box 90 degrees left and right.He ensured the stylet was pushed all the way down before placing it into the measuring tool.Another lead test cable kit was opened, and the same issue occurred with both the impedance check out of range and connectivity test failing.We then opened a new 1.5mm lead, reconnected with lead test cable and the connectivity test passed and impedance check came back all within normal ranges.Additional information received from rep indicating that cause of the impedance remains unknown.They elaborate that the lead with high impedance was replaced and was returned for analysis.Rep explains that to troubleshoot they re-ran impedance and connectivity test again with the lead, but when it continued to fail, they first opened a new lead test cable, impedance test and connectivity test failed again and the neurosurgeon requested a new lead to be opened.When new lead was opened and both impedance and connectivity test were run, no issues or failures occurred.
Additional Manufacturer Narrative
The returned device (b3301542m, s/n:(b)(6) was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.The returned device passed all testing in the laboratory and no anomalies were identified.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
See h.11.

• Brand Name: SENSIGHT
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: 24334534
• Report Number: 2649622-2026-04302
• Device Sequence Number: 9790545
• Product Code: MHY
• UDI-Device Identifier: 00763000426446
• UDI-Public: (01)00763000426446(17)271002
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 03/06/2026

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: B3301542M
• Device Catalogue Number: B3301542M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2025
• 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: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female