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

Model Number	B3301542
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during phase i implant, the lead was connected to the test cable and connectivity and impedance tests failed.The lead was reconnected to test cable, ran impedances along with connectivity test and both failed again.Troubleshooting included replacing the test cable and repeated noted tests for this lead; both tests failed.A second lead was opened and placed and that lead also failed both the connectivity and impedance test using both of the opened test cables previously noted.A third lead was opened and placed and this passed both tests.
Additional Manufacturer Narrative
Continuation of d10: product id neu_stylet_acc.Serial# unknown: product type accessory product id neu_stylet_acc serial# unknown: product type accessory product id b3301542 serial# (b)(6).Implanted: (b)(6) 2025.Explanted: (b)(6) 2025 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.
Additional Manufacturer Narrative
The returned device 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.Continuation of d10: product id neu style t acc, serial# unknown, product type accessory product id neu stylet acc, serial# unknown, product type accessory product id b3301542, serial# (b)(6), implanted: (b)(6) 2025, explanted: (b)(6) 2025, 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 ESSENTIAL 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: 23030489
• Report Number: 2649622-2025-25222
• Device Sequence Number: 13216543
• Product Code: PJS
• UDI-Device Identifier: 00763000426439
• UDI-Public: (01)00763000426439(17)270602
• 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,Followup
• Report Date (Section B): 10/08/2025

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: B3301542
• Device Catalogue Number: B3301542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 41 YR
• Patient Sex: Male