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

Model Number	B3400060M
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient was in a stage 2 implant case for a dbs system.They had an issue with high impedance value on electrode 9a.They tested the lead with the lead test cable and ens, all impedance indicators were green.When the extension was connected the value for 9a was high again, they connected the extension to the second lead and the same segment electrode had a high value.They opened a second extension and it showed a high value for electrode 9a and the corresponding segment when the new extension was connected to the 0-3 lead.Troubleshooting was not required.The issue was not resolved through troubleshooting.Tech services reviewed troubleshooting considerations.The caller planned to get another extension.Additional information was received from manufacturer representative (rep).Rep reported the cause of the impedances was unknown, but suspect contributing factors may have included intermittent issue and possible positioning of patient during surgery.Rep reported impedances were not cleared during surgery.Surgeon could not clear impedance issue on 9a during surgery and was to add a note that they would provide therapy around the segment.Surgeon opened 3 marked leads and an additional battery because he was not confident it wasn't a battery issue.Impedances cleared in post anesthesia care unit.Rep reports issue was resolved.
Additional Manufacturer Narrative
Continuation of d10: product id b3400060m serial# (b)(6) implanted: (b)(6) 2026; product type extension product id b3400060m serial# (b)(6) product type extension.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 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: 25564580
• Report Number: 2649622-2026-18358
• Device Sequence Number: 9995040
• Product Code: MHY
• UDI-Device Identifier: 00763000426484
• UDI-Public: (01)00763000426484(17)271217
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2026

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: B3400060M
• Device Catalogue Number: B3400060M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/19/2026
• Date Device Manufactured: 12/17/2025
• 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...."
• Patient Age: 76 YR
• Patient Sex: Male